FDA: Class I recall of Arrow AutoCAT2, AC3 IABPs

Editor's Note

The Food and Drug Administration (FDA), on December 20, identified the recall by Arrow International, LLC, subsidiary of Teleflex, Inc, of its Arrow AutoCAT 2 and AC3 intra-aortic balloon pumps (IABPs) as Class I, the most serious.

IABPs are used in patients having cardiac and non-cardiac surgery, and in patients with acute coronary syndrome or heart failure.

The recall was initiated because of unexpectedly short battery run times. A fully charged battery should last 90 minutes, but multiple users report the devices are experiencing shorter run times. Sudden stopping of the pump can lead to cardiac arrest, stroke, or death.

There have been 241 complaints, with 135 pump stops, and no deaths related to this issue.

Distribution dates were July 1, 2022, to September 30, 2022.