Device product
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AC3 IABP NA/AJLA, REF IAP-0601(IPN917288), cardiac pump
Z-0437-2023
Product summary
- Event
- Event 91021
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-0437-2023
Official wording
Reason: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Code information: UDI/DI (01) 2 0801902 17209 3, (01) 2 0801902 17209 6, All Lot/Serial Numbers
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.