FDAFDA · Food and drugs·Recall number Z-0438-2023
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), 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 08496 5, (01) 0 0801902 08496 6, All Lot/Serial Numbers
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.