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

Recall date

May 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2412-2020

FDA classification

Class I

Brand / firm

Arrow International Inc

Sold / distributed

Worldwide distribution.

Why it was recalled

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.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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