Z-0429-2023 Class I Ongoing
FDA device recall Z-0429-2023 was initiated by ARROW INTERNATIONAL Inc. on October 17, 2022 and is designated Class I. Reason for recall: There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices. The recall status is ongoing. Affected quantity: 2678 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 21, 2022
- Initiation Date
- October 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2678 units
Product Description
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 WAVE, REF IAP-0500 (IPN000320), cardiac pump
Reason for Recall
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Distribution Pattern
Worldwide
Code Information
UDI/DI (01) 0 0801902 05171 4, (01) 0 0801902 05171 5, All Lot/Serial Numbers