Reported Dec 21, 2022 · Ongoing
Arrow AC3 Optimus Intra-Aortic Balloon Pump, AC3 Optimus IABP NA/EMEA, REF IAP-0700 (IPN001112), cardiac pump
ARROW INTERNATIONAL Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ARROW INTERNATIONAL Inc. · 3015 Carrington Mill Blvd · Morrisville, NC · 27560-5437
Is this the product you have?
Arrow AC3 Optimus Intra-Aortic Balloon PumpAC3 Optimus IABP NA/EMEAREF IAP-0700 (IPN001112)cardiac pump
- Lot codes and dates
UDI/DI (01) 0 0801902 08496 5(01) 0 0801902 08496 6All Lot/Serial Numbers
- Amount recalled
- N/A
This recall covers 33 products
The agency filed one notice per product. You are reading one of them; the other 32 are below.
20 more are in the archive.
Why it was recalled
Stop using this product now
There is a potential issue with short battery run-times on the affected intra-aortic balloon pump (IABP) devices.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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