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Lower risk Medical device recall · FDA · Published October 17, 2022

Arrow AutoCAT2 Intra-Aortic Balloon Pump Recall: Short Battery Run-Times

Arrow recalls AutoCAT2 Intra-Aortic Balloon Pumps with potential short battery run-times. Affected units may require replacement due to battery issues.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0432-2023Medical deviceArrow ›
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Contact the company

Recalling firmARROW INTERNATIONAL Inc.3015 Carrington Mill Blvd · Morrisville, NC 27560-5437
✎ GovInfoNow plain-language explainer

What happened, in plain English

Arrow is recalling certain intra-aortic balloon pumps that may have short battery run-times. This could lead to the pump failing during use, which is critical for patients with heart conditions. Read more at govinfonow.com/recall/59875-arrow-autocat2-intra-aortic-balloon-pump-recall-short-battery-run.

Source Summary by GovInfoNow · govinfonow.com/recall/59875-arrow-autocat2-intra-aortic-balloon-pump-recall-short-battery-run · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0432-2023

Cite this page

“Arrow AutoCAT2 Intra-Aortic Balloon Pump Recall: Short Battery Run-Times.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59875-arrow-autocat2-intra-aortic-balloon-pump-recall-short-battery-run. Based on FDA recall #Z-0432-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0432-2023%22&limit=1).

Why it’s dangerous

The pumps may run out of battery faster than expected, potentially causing the device to stop working during critical medical procedures. This could lead to complications for patients with heart conditions who rely on the pump.

Who’s affected

Patients using the recalled intra-aortic balloon pumps for heart support are affected. Healthcare providers who use these pumps in medical settings are most at risk.

How to tell if you have this one

Check for the model number 'AutoCAT2' or the serial number starting with '01 0 0801902 05173 8' on the pump. The product was sold with specific lot and serial numbers listed in the recall notice.

  • Brand
    Arrow
  • Category
    Medical device
FDA recall event · 31 products

All 31 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class I
  • Status
    Ongoing
  • Distribution
    Worldwide
Recall numberProduct, codes & lotsQuantity
Z-0426-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump; UDI/DI (01) 0 0801902 05172 1, (01) 0 0801902 05172 2, All Lot/Serial Numbers1394 units
Z-0427-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump; UDI/DI (01) 0 0801902 09375 2, (01) 0 0801902 09375 3, All Lot/Serial Numbers6 units
Z-0428-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2, REF IAP-0435 (IPN000312), cardiac pump; UDI/DI (01) 0 0801902 05174 5, (01) 0 0801902 05174 6, All Lot/Serial Numbers12 units
Z-0429-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump; UDI/DI (01) 0 0801902 05171 4, (01) 0 0801902 05171 5, All Lot/Serial Numbers2678 units
Z-0430-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE REFURBISHED, REF IAP-0500X (IPN000328), cardiac pump; UDI/DI (01) 0 0801902 09391 2, (01) 0 0801902 09391 3, All Lot/Serial Numbers88 units
Z-0431-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump; UDI/DI (01) 0 0801902 05173 8, (01) 0 0801902 05173 9, All Lot/Serial Numbers81 units
Z-0432-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT2 WAVE REFURBISHED, REF IAP-0535X (IPN000329), cardiac pump; UDI/DI (01) 0 0801902 05173 8 (11) 170825 (21) 999999W, All Lot/Serial Numbers1 unit
Z-0433-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN001108), cardiac pump; UDI/DI (01) 0 0801902 08495 8, (01) 0 0801902 08495 9, All Lot/Serial NumbersN/A
Z-0434-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/EMEA, REF IAP-0600 (IPN917287), cardiac pump; UDI/DI (01) 2 0801902 17208 6, (01) 2 0801902 17208 9, All Lot/Serial NumbersN/A
Z-0435-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601 (IPN001109), cardiac pump; UDI/DI (01) 0 0801902 09118 5, (01) 0 0801902 09118 6, All Lot/Serial NumbersN/A
Z-0436-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN916548), cardiac pump; UDI/DI (01) 2 0801902 18177 4, (01) 2 0801902 18177 7, All Lot/Serial NumbersN/A
Z-0437-2023Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump; UDI/DI (01) 2 0801902 17209 3, (01) 2 0801902 17209 6, All Lot/Serial NumbersN/A
Z-0438-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump; UDI/DI (01) 0 0801902 08496 5, (01) 0 0801902 08496 6, All Lot/Serial NumbersN/A
Z-0439-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700(IPN917285), cardiac pump; UDI/DI (01) 2 0801902 17206 2, (01) 2 0801902 17206 5, All Lot/Serial NumbersN/A
Z-0440-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus REFURBISHED, REF IAP-0700X (IPN914274), cardiac pump; UDI/DI (01) 2 0801902 14277 5, (01) 2 0801902 14277 8, All Lot/Serial NumbersN/A
Z-0441-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), cardiac pump; UDI/DI (01) 0 0801902 09125 3, (01) 0 0801902 09125 3, All Lot/Serial NumbersN/A
Z-0442-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN916549), cardiac pump; UDI/DI (01) 1 0801902 18178 4, (01) 1 0801902 18178 7, All Lot/Serial NumbersN/A
Z-0443-2023Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN917286), cardiac pump; UDI/DI (01) 2 0801902 17207 9, (01) 2 0801902 17207 2, All Lot/Serial NumbersN/A
Z-0444-2023Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump; UDI/DI (01) 3 0801902 09203 9, (01) 0 0801902 09203 8, All Lot/Serial Numbers29 units
Z-0445-2023Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400F (IPN000306), cardiac pump; UDI/DI (01) 0 0801902 09205 2, (01) 3 0801902 09205 3, All Lot/Serial Numbers1 unit
Z-0446-2023Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400J (IPN000308), cardiac pump; UDI/DI (01) 0 0801902 04341 2, (01) 3 0801902 04341 3, All Lot/Serial Numbers4 units
Z-0447-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500D (IPN000321), cardiac pump; UDI/DI (01) 0 0801902 09217 5, (01) 3 0801902 09217 6, All Lot/Serial Numbers39 units
Z-0448-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500E (IPN000322), cardiac pump; UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers112 units
Z-0449-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), cardiac pump; UDI/DI (01) 0 0801902 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers1 unit
Z-0450-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500F (IPN000323), cardiac pump; UDI/DI (01) 0 0801902 09218 2, (01) 3 0801902 09218 3, All Lot/Serial Numbers48 units
Z-0451-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump; UDI/DI (01) 0 0801902 09219 9, (01) 3 0801902 09219 0, All Lot/Serial NumbersN/A
Z-0452-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000325), cardiac pump; UDI/DI (01) 0 0801902 04342 9, (01) 3 0801902 04342 0, All Lot/Serial Numbers127 units
Z-0453-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500NL (IPN000326), cardiac pump; UDI/DI (01) 0 0801902 09172 7, (01) 3 0801902 09172 8, All Lot/Serial Numbers4 units
Z-0454-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500SV (IPN000327), cardiac pump; UDI/DI (01) 0 0801902 09173 4, (01) 3 0801902 09173 5, All Lot/Serial Numbers15 units
Z-0455-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-05001 (IPN000333), cardiac pump; UDI/DI (01) 0 0801902 09177 2, (01) 3 0801902 09177 3, All Lot/Serial Numbers1 unit
Z-0456-2023Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500J (IPN000334), cardiac pump; UDI/DI (01) 0 0801902 09178 9, (01) 3 0801902 09178 0, All Lot/Serial Numbers1 unit
Based on the official FDA remedy

What to do — step by step

  1. Check Battery Status

    Verify if the pump has short battery run-times by testing the device's battery life.

How this recall unfolded

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Oct 17, 202212. FDA classified it Class I: Dec 15, 202223. Published in FDA’s Enforcement Report: Dec 21, 202232022
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0432-2023 (October 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0432-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA