Reported Jul 8, 2020 · Terminated
Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
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 · 2400 Bernville Rd · Reading, PA · 19605-9607
Is this the product you have?
- Arrow AC3 Optimus Intra-Aortic Balloon Pump AC3 Optimus IABP NA/AJLA, Product Code IAP-0701
- Lot codes and dates
- Serial Number RangesAC3 Optimus IABP NA/AJLA IAP-0701 170831F through 170840F 171011F through 171020F 171121F through 171125F 180106F through 180110F 180126F through 180130F 180426F through 180430F 180606F through 180610F 180731F through 180740F 180826F through 180830F 180901F through 180910F 180912F through 180921F 181001F through 181010F 190136F through 190140F 190336F through 190340F 190646F through 190650F 190731F through 190736F 190931F through 190936F 191019F through 191024F 191055F through 191060F 200107F through 200112F 200308F through 200311F
- Amount recalled
- 2123 total
This recall covers 10 products
The agency filed one notice per product. You are reading one of them; the other 9 are below.
Why it was recalled
Stop using this product now
A potential issue with a component within the above-referenced IABPs may impact the ability of the devices to operate. A Component within the IABP is susceptible to vibration failure resulting in fretting, charring, and discoloration of motor connector wires, which may result in pump alarms for System Error 3 and High Baseline presented on the screen of the IABP, and potential abrupt cessation of function or inability to start the IABP.
Using this product could cause serious injury, illness or death — stop using it now.
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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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