CLASS I ONGOING Device recall · Reported 21 Dec 2022 · FDA Enforcement Report
Arrow AutoCAT2 Intra-Aortic Balloon Pump, Autocat 2 Iapb recalled
Arrow International is recalling Arrow AutoCAT2 Intra-Aortic Balloon Pump, Autocat 2 Iapb. The recall was initiated on 17 Oct 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0426-2023
- FDA event ID
- 91021
- Recalling firm
- Arrow International, Morrisville, NC
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 17 Oct 2022
- FDA classified
- 15 Dec 2022
- Reported
- 21 Dec 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Heart & Vascular Devices
Timeline
| 17 Oct 2022 | Recall initiated by company | |
| 15 Dec 2022 | Classified by FDA | +59 days |
| 21 Dec 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT 2 IAPB, REF IAP-0400 (IPN000302), cardiac pump
Where it was distributed
Worldwide
Questions about this recall
Is Arrow AutoCAT2 Intra-Aortic Balloon Pump, Autocat 2 Iapb recalled?
Yes. Arrow International recalled Arrow AutoCAT2 Intra-Aortic Balloon Pump, Autocat 2 Iapb on 17 Oct 2022. The recall is Class I and its status is Ongoing. Recall number Z-0426-2023.
Why was it recalled?
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Which lots are affected?
UDI/DI (01) 0 0801902 05172 1, (01) 0 0801902 05172 2, All Lot/Serial Numbers
Where was it sold?
Worldwide
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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