FDAFDA · Food and drugs·Recall number Z-0431-2023
Arrow AutoCAT2 Intra-Aortic Balloon Pump, AEROAUTOCAT 2 WAVE, REF IAP-0535 (IPN000329), cardiac pump
Published December 21, 2022 · Recall initiated: October 17, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ARROW INTERNATIONAL Inc.
- Distributor
- Worldwide
- Lot
- UDI/DI (01) 0 0801902 05173 8, (01) 0 0801902 05173 9, All Lot/Serial Numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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