thejoe Datascope Corporation

Datascope Corporation: 67 FDA recall reports

Every medical device recall the FDA has published for Datascope Corporation. The fault, and how the agency graded it.

67Reports

0Class I

21Ongoing

2022-11-02Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	63
Class III	4

By year reported

Year	Reports
2014	1
2016	2
2017	2
2018	37
2019	1
2020	20
2022	4

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.

Z-0131-2023 · Class II · reported 2022-11-02 · Ongoing

Why it was recalled: The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy. Therapy delays may impact those patients who are more hemodynamically unstable.
Product: LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
Where it went: No US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile, Columbia, Ecuador, Egypt, France, Indonesia, Israel, Italy, Jordan, Kenya, Malaysia, Mexico, Netherlands, Pakistan, Poland, Portugal, South Korea, Russia, Spain, Turkmenistan, United Arab Emirates, United Kingdom, Uruguay.
How much: 4414 OUS

MEGA 8Fr 50cc Intra-Aortic Balloon Catheter

Z-1685-2022 · Class II · reported 2022-09-14 · Ongoing

Why it was recalled: Certain lots containing undersized dilator.
Product: MEGA 8Fr 50cc Intra-Aortic Balloon Catheter
Where it went: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
How much: 10,427 units

Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter

Z-1686-2022 · Class II · reported 2022-09-14 · Ongoing

Why it was recalled: Certain lots containing undersized dilator.
Product: Sensation Plus 8Fr 50cc Intra-Aortic Balloon Catheter
Where it went: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
How much: 10,427 units

Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter

Z-1687-2022 · Class II · reported 2022-09-14 · Ongoing

Why it was recalled: Certain lots containing undersized dilator.
Product: Insertion Kit for use with SENSATION PLUS 8F. 50cc Intra-Aortic Balloon Catheter
Where it went: Awaiting domestic distribution. Foreign: Australia, Belgium, Canada, Czech Republic, France, Germany, Hong Kong, Iceland, Ireland, Italy, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
How much: 10,427 units

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01

Z-2839-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 34cc IAB Kit P/N: 0684-00-0479-01, 0684-00-0479-01C, 0684-00-0479-01U, 0684-00-0479-02, 0684-00-0479-02U, 0684-00-0479-07, 0684-00-0479-08, 0684-00-0479-10 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 54816 Kits WW

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For

Z-2842-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure. Kit P/N: 0684-00-0546-01
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 3059 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - P

Z-2843-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0607 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 12032 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,06

Z-2833-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N: 0684-00-0296-01, 0684-00-0296-01U,0684-00-0296-02, 0684-00-0296-02U, 0684-00-0296-10; 0684-00-0498-01, 0684-00-0498-07, 0684-00-0498-08 Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 31529 WW

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0

Z-2837-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit P/N: 0684-00-0576-01, 0684-00-0576-01U, 0684-00-0576-05, 0684-00-0576-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 69278 kits

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-

Z-2838-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N: 0684-00-0478-01, 0684-00-0478-01C, 0684-00-0478-01U 0684-00-0478-02, 0684-00-0478-02U - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 1746 kits WW

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 -

Z-2846-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB (Japan) Kit P/N: 0684-00-0560-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 3542 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U,

Z-2831-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB, P/N: 0684-00-0294-01,0684-00-0294-01U, 0684-00-0294-02, 0684-00-0294-02U- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 1275 kits WW

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 -

Z-2847-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0561-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 3055 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Produc

Z-2841-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB (Japan) Kit P/N: 0684-00-0545-01- Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 2550 Kits

Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U

Z-2832-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N: 0684-00-0295-01, 0684-00-0295-01U, 0684-00-0295-02, 0684-00-0295-02U, 0684-00-0295-05, 0684-00-0295-07, 0684-00-0295-09, 0684-00-0295-10 -Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 16104 WW

Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 -

Z-2845-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB (Japan) Kit P/N: 0684-00-0559-01 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 6111 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-0

Z-2836-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB Kit P/N: 0684-00-0568-01, 0684-00-0568-01U, 0684-00-0568-05, 0684-00-0568-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 29653 kits WW

Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - P

Z-2844-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB (Japan) Kit P/N: 0684-00-0608 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 11555 Kits

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-0

Z-2835-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N: 0684-00-0470-01, 0684-00-0470-01U, 0684-00-0470-07, 0684-00-0470-09 - Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 32855 kits

Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-0

Z-2840-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 40cc IAB Kit P/N: 0684-00-0480-01, 0684-00-0480-01U, 0684-00-0480-01C, 0684-00-0480-02, 0684-00-0480-02C, 0684-00-0480-02U, 0684-00-0480-07, 0684-00-0480-08, 0684-00-0480-10
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 116652 Kits WW

Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469

Z-2834-2020 · Class II · reported 2020-09-02 · Ongoing

Why it was recalled: Potential Endotoxin Contamination
Product: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 34cc IAB Kit, P/N: 0684-00-0469-01, 0684-00-0469-01C, 0684-00-0469-01U, 0684-00-0469-07, 0684-00-0469-09. Product Usage: Indications For Use: Acute Coronary Syndrome Cardiac and Non-Cardiac Surgery Complications of Heart Failure.
Where it went: Worldwide distribution - US Nationwide distribution and the countries of Argentina, Austrailia Austria Belgium Brazil Canada Chile Colombia Czech Republic Denmark Finland France Germany Hong Kong India Ireland Italy Japan Korea Mexico Netherlands New Zealand Norway Paraguay Poland Portugal Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Kenya, South Africa, Israel, Mauritus, Nigeria, South Africa, Namibia, Uganda.
How much: 13335 WW

Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percuta

Z-0934-2020 · Class II · reported 2020-02-12 · Terminated

Why it was recalled: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Product: Reinforced Introducer Sets Maquet 8 Fr., Part Number: 068400040310. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Where it went: US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia
How much: 523

Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for per

Z-0932-2020 · Class II · reported 2020-02-12 · Terminated

Why it was recalled: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Product: Reinforced Introducer Sets Maquet 7 Fr., Part Number: 0684 00 0403 06. It is an accessory to be used for percutaneous insertion of MAQUET Intra Aortic Balloon Catheters.
Where it went: US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia
How much: 102

Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percu

Z-0933-2020 · Class II · reported 2020-02-12 · Terminated

Why it was recalled: Potential for compromised sterility in breached pouches of specific lots of Reinforced Introducer Sets Maquet 7 Fr., 7.5 Fr. and 8 Fr. IABs.
Product: Reinforced Introducer Sets Maquet 7.5 Fr., Part Number: 068400040305. It is an accessory to be used for percutaneous insertion of MAQUET IntraAortic Balloon Catheters.
Where it went: US: AK AL AZ CA CO CT FL GA IA ID IL IN KS KY LA MD MI MN MO MS NC ND NE NJ NY OH OK PA SC SD TN TX VA WA WI WV OUS: Switzerland, Netherlands, South Africa, Canada, Germany, Austria, Spain, Italy, Poland, Bharain, Malaysia
How much: 676

Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Prod

Z-1966-2019 · Class II · reported 2019-07-24 · Terminated

Why it was recalled: The device was distributed with the outer carton labeled with the manufacture date and the expiry date reversed. This showed the product as expired before it was manufactured.
Product: Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories, Part Number 0684-00-0568-01 Product Usage: The Sensation Plus 7.5Fr. 40cc Intra-Aortic Balloon Catheter with accessories is a device that includes a catheter, an insertion kit and two STATLOCK IAB stabilization devices. It is a cardiac assist device intended to provide counterpulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
Where it went: The products were distributed to the following US states: FL. The products were distributed to the following foreign countries: Australia, Austria, Belgium, Estonia, France, Germany, Ireland, Italy, Kuwait, Lithuania, Malaysia, Mexico, Netherlands, Poland, Russia, Saudi Arabia, Slovakia, Sweden, Switzerland, United Kingdom, Ukraine.
How much: 471

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage

Z-2178-2018 · Class II · reported 2018-06-20 · Terminated

Why it was recalled: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Where it went: The products were distributed to the following US states: IA and FL.
How much: 10

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product

Z-2179-2018 · Class II · reported 2018-06-20 · Terminated

Why it was recalled: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 4906 PEDIARIC CPB PACK, Part Number 701056041 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Where it went: The products were distributed to the following US states: IA and FL.
How much: 27

Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Us

Z-2180-2018 · Class II · reported 2018-06-20 · Terminated

Why it was recalled: There is a potential for the over-pressure safety (OPS) valve in the tubing kits to not allow flow through.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
Where it went: The products were distributed to the following US states: IA and FL.
How much: 8

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992

Z-2106-2018 · Class III · reported 2018-06-13 · Terminated

Why it was recalled: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-TOP 5909 14 Pack QPID, Part Number 701064992
Where it went: The products were distributed to the following US states: AL, OR, and TX.
How much: 19 total kits

Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588

Z-2104-2018 · Class III · reported 2018-06-13 · Terminated

Why it was recalled: There is a potential problem with the cuvette where failure of the cuvette would cause an error message on the monitor display of H/S DISCONNECT AT CUVETTE.
Product: Maquet Cardiopulmonary Bypass Custom Tubing kit BEQ-T 5208 ECC SET, Part Number 701054588
Where it went: The products were distributed to the following US states: AL, OR, and TX.
How much: 19 total kits

Showing the 30 most recent of 67. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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