FDA-Device2020-07-08Class I
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Arrow International Inc
Hazard
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.
Sold states
Worldwide distribution.
Affected count
2123 total
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2412-2020Don't want to check this manually?
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