Reported Jul 8, 2020 · Terminated
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
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 AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH, Product Code IAP-0500E
- Lot codes and dates
- Serial Number RangesAUTOCAT2 WAVE SPANISH IAP-0500E 150302W 150304W 150402W throughthrough 160427W 160508W through 160510W 160518W Arrow AutoCAT 2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE SPANISH
150403W150408W150514W150826W151014W151107W151110W160425W
throughIAP-0500E160631W160637W160642W160644W160705W160919W170204W
through 181060W 190229W 190512W 190514W 190519W 190631W through 190633W170206W170221W170308W170328W170928W171116W180333W180840W180939W181054W181056W
- Serial Number RangesAUTOCAT2 WAVE SPANISH IAP-0500E 150302W 150304W 150402W through
- 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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