Z-0441-2023 Class I Ongoing
FDA device recall Z-0441-2023 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.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2022
- Initiation Date
- Oct 17, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/AJLA, REF IAP-0701 (IPN001113), 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 09125 3, (01) 0 0801902 09125 3, 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-0441-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026