FDA Device recall Z-0444-2023
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
- FDA Device
- Class I
- ongoing
- Published 2022-12-21
On 2022-12-21 the FDA classified a Class I recall of Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump by Arrow International, citing there is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0444-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2022-10-17 |
| Published | 2022-12-21 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Arrow International |
| Distribution | n/a |
Product
Arrow AutoCAT 2 Intra-Aortic Balloon Pump, Arrow AutoCAT 2 IABP, REF IAP-0400E (IPN000305), cardiac pump
Reason
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Identifiers
| code_info | UDI/DI (01) 3 0801902 09203 9, (01) 0 0801902 09203 8, All Lot/Serial Numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0444-2023%22
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