FDA Recall for Arrow International, LLC, a subsidiary of Teleflex, Inc
Arrow International, LLC, a subsidiary of Teleflex, Inc, is recalling Arrow AutoCAT 2 and AC3 Intra-Aortic Balloon Pumps after receiving complaints that battery power is not lasting as expected. The FDA has identified this as a Class I recall. A fully charged battery should last 90 minutes; however, multiple users report the devices are experiencing shorter run times. The battery life warnings, designed to sound at 20, 10, and 5 minutes of battery power remaining, are also inaccurate as the battery depletes more rapidly than indicated. There have been 241 complaints, with 135 reported pump stops. No deaths have been reported related to this issue.