Z-0449-2023 Class I Ongoing
FDA device recall Z-0449-2023 was initiated by ARROW INTERNATIONAL Inc. on Oct 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: 1 unit.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Oct 17, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
Product Description
Arrow AutoCAT2WAVE Intra-Aortic Balloon Pump, Arrow AutoCAT2WAVE IABP, REF IAP-0500EX (IPN000322), 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 09216 8, (01) 3 0801902 09216 9, All Lot/Serial Numbers
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0449-2023
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026