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Recall Observatory FDA recall evidence

Device product

Arrow AutoCAT2 Intra-Aortic Balloon Pump AEROAUTOCAT 2 WAVE, Product Code IAP-0535

Z-2415-2020

May 20, 2020

Class I

Product summary

Firm
Arrow International Inc
Event
Event 85684
Status
Terminated
Classification
Class I
Quantity
2123 total
Official record key
device-enforcement:Z-2415-2020

Official wording

Reason: 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.

Code information: Serial Number Range: AEROAUTOCAT 2 WAVE IAP-0535 150907W 151030W 151101W 151104W 151106W 160305W through 160306W 160743W 160824W 190119W through 190120W 190221W 190223W through 190226W 191047W

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.