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Recall Observatory FDA recall evidence

Device product

Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALIAN, Product Code IAP-0500I

Z-2412-2020

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-2412-2020

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 Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W

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.