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Arrow International Inc
Arrow International Inc: 478 FDA recall reports
Every medical device recall the FDA has published for Arrow International Inc. The fault, and how the agency graded it.
478Reports
57Class I
50Ongoing
2024-10-02Most recent
57 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
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 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
By year reported
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.
Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Cat
Z-3299-2024 · Class II · reported 2024-10-02 · Ongoing
- Why it was recalled
- Reports have been received regarding open seals on the packaging.
- Product
- Arrow Arterial Kits and Trays as follows: (1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1; (2) Arrow Arterial Access Tray with 0.021" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-CK; (3) Arrow Arterial Access Kit, .025 inch dia. spring-wire guide, REF ASK-04001-VAMC1; (4) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-BHS; (5) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-BID; (6) Arrow Arterial Line Kit, 20 Ga., 12 cm. catheter length, .025 inch dia. spring-wire guide, REF ASK-04020-HMC; (7) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-HOA; (8) Arrow Arterial Catheterization Kit, 20 Ga., 4.45 cm. catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-KSD; (9) Arrow Arterial Catheterization Kit, 20 Ga. 4.45 cm catheter length, .018 inch dia. spring-wire guide, REF ASK-04020-LOL; (10) Arrow Radial Catheterization, 20 Ga. 4.45 cm catheter length, .018 inch...
- Where it went
- US Nationwide distribution in the states of CA, FL, GA, IL, MA, ME, MI, NC, NY, PA, and WV. There was government distribution.
- How much
- 14,845 kits
Class I
Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB
Z-1878-2024 · Class I · reported 2024-06-12 · Ongoing
- Why it was recalled
- Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
- Product
- Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a) REF IAB-05830-LWS; b) REF IAB-05840-LWS; c) REF IAB-05850-LWS
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
- How much
- 7939 units
Class I
Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850
Z-1879-2024 · Class I · reported 2024-06-12 · Ongoing
- Why it was recalled
- Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
- Product
- Arrow UltraFlex Intra-Aortic Balloon Catheter Kit, a) REF IAB-06830-U; b) REF IAB-06840-U; c) REF IAB-06850-U
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
- How much
- 44,807 units
Class I
Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
Z-1880-2024 · Class I · reported 2024-06-12 · Ongoing
- Why it was recalled
- Teleflex received reports indicating an infrequent condition that, when not identified and corrected promptly, could result in serious health consequences. The issue may manifest as: -failure of the intra-aortic balloon to completely inflate over its full length -damaged or broken central lumen in the segment contained within the balloon -helium loss or blood in the helium pathway.
- Product
- Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit, a) REF IAB-05830-U; b) REF IAB-05840-U
- Where it went
- Worldwide distribution. US nationwide including Puerto Rico, AU, BA, BE, BG, BN, CA, CL, CN, CO, CY, CZ, DE, EC, ES, FR, GB, GP, GR, HU, HK, IE, IL, IN, IQ, IT, JO, JP, KW, KZ, LB, LU, MA, MN, MK, MX, MY, NL, OM, PA, PF, PH, PL, PT, QA, RE, RO, RS, SA, SE, SG, SI, SK, TH, TR, TW, UZ, ZA, and UAE.
- How much
- 3138 units
Class I
ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) R
Z-1267-2024 · Class I · reported 2024-03-27 · Ongoing
- Why it was recalled
- Teleflex is initiating this voluntary recall for the above-mentioned products due to reports received indicating a potentially defective component. The complaints received relate to resistance of the guidewire handle/chamber during use. The possible immediate health consequences of the component issue are arterial vasospasm and vessel injury arising from multiple arterial punctures with repeated attempts.
- Product
- ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers: a) REF AK-04220; b) REF ASK-04220-FMH1; c) REF ASK-04220-HHC; d) REF ASK-04220-KSP; e) REF ASK-04220-PSU; f) REF ASK-04220-UCL1; g) REF ASK-04500-AH; h) REF ASK-04500-HF-S; i) REF NA-04220-S1A; j) REF NA-04220-X1A; k) REF RA-04220; l) REF RA-04220-W
- Where it went
- Worldwide distribution: US (nationwide) and OUS (foreign) to countries of: AE, AR, AT, AU, BE, BH, BR, CA, CN, CO, CY, DE, EC, EE, ES, FR, GR, HK, HR, IT, KW, LB, LU, MX, MY, NL, NZ, PH, PL, QA, RU, SA, SE, SG, SI, TH, TW, and UK.
- How much
- 1,160,470 devices
Class I
Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTrack
Z-0004-2024 · Class I · reported 2023-10-11 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, long-term greater than 30 days
- Where it went
- US
- How much
- 172 units
Class I
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; cathe
Z-0002-2024 · Class I · reported 2023-10-11 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Where it went
- US
- How much
- 180 units
Class I
Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision
Z-0001-2024 · Class I · reported 2023-10-11 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter
- Where it went
- US
- How much
- 1173 units
Class I
Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, th
Z-0003-2024 · Class I · reported 2023-10-11 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Where it went
- US
- How much
- 380 units
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Z-2590-2023 · Class II · reported 2023-09-27 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
- Where it went
- US Nationwide distribution.
- How much
- 190 units
Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Cathet
Z-2591-2023 · Class II · reported 2023-09-27 · Ongoing
- Why it was recalled
- This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
- Product
- Arrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
- Where it went
- US Nationwide distribution.
- How much
- 177 units
Class I
ARROW Endurance Extended Dwell Peripheral Catheter System
Z-1826-2023 · Class I · reported 2023-06-28 · Ongoing
- Why it was recalled
- Potential for catheter separation or leakage
- Product
- ARROW Endurance Extended Dwell Peripheral Catheter System
- Where it went
- Nationwide distribution. International distribution to Canada.
- How much
- 262,016 units
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac
Z-0432-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump
- Where it went
- Worldwide
- How much
- 1 unit
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac p
Z-0455-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump
- Where it went
- Worldwide
- How much
- 1 unit
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Z-0431-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
- Where it went
- Worldwide
- How much
- 81 units
Class I
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pu
Z-0438-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pu
Z-0442-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
Z-0428-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump
- Where it went
- Worldwide
- How much
- 12 units
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
Z-0433-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac
Z-0454-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump
- Where it went
- Worldwide
- How much
- 15 units
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac
Z-0453-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump
- Where it went
- Worldwide
- How much
- 4 units
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Z-0426-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
- Where it went
- Worldwide
- How much
- 1394 units
Class I
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
Z-0446-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump
- Where it went
- Worldwide
- How much
- 4 units
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac p
Z-0450-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump
- Where it went
- Worldwide
- How much
- 48 units
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
Z-0436-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pu
Z-0443-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pum
Z-0439-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac p
Z-0448-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump
- Where it went
- Worldwide
- How much
- 112 units
Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Z-0437-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
- Where it went
- Worldwide
- How much
- N/A
Class I
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac p
Z-0447-2023 · Class I · reported 2022-12-21 · Ongoing
- Why it was recalled
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Product
- Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump
- Where it went
- Worldwide
- How much
- 39 units
Showing the 30 most recent of 478. 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.
← All device recalls