Device product
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500I (IPN000324), cardiac pump
Z-0451-2023
Product summary
- Event
- Event 91021
- Status
- Ongoing
- Classification
- Class I
- Quantity
- N/A
- Official record key
device-enforcement:Z-0451-2023
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) 0 0801902 09219 9, (01) 3 0801902 09219 0, 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.