Recall archive / FDA device enforcement
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump — FDA record Z-0427-2023
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Oct 17, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Arrow AutoCAT2 Intra-Aortic Balloon Pump, AUTOCAT2 IAPB, REFURBISHED, REF IAP-0400X (IPN000311), cardiac pump
- Reason
- There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
- Classification
- Class I
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 6 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-0427-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | UDI/DI (01) 0 0801902 09375 2, (01) 0 0801902 09375 3, All Lot/Serial Numbers |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Dec 21, 2022
- Recall initiation date
- Oct 17, 2022
- Center classification date
- Dec 15, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.