medical Class I Updated 2020-07-08

Arrow International Inc recalls Arrow AutoCAT2 Intra-Aortic Balloon Pump AUTOCAT2 WAVE ITALI

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Distribution: Worldwide distribution.
Lot/Code Info: Serial Number Ranges: AUTOCAT2 WAVE ITALIAN IAP-0500I 160516W 160619W 160804W 160828W 170209W through 170210W 170302W 180309W
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