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Arrow International, LLC, a Subsidiary of Teleflex, Inc. Recalls Arrow AutoCAT 2, AC3 Intra-Aortic Balloon Pumps for Unexpectedly Short Battery Run Times
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 long as expected. A fully charged battery should last 90 minutes, however, multiple users report the devices are experiencing shorter run times. When the device is experiencing a short battery run time, 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. If the pump’s battery depletes, the pump may stop when operating on battery power only.
The U.S. Food and Drug Administration (FDA) has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Questions?
If you have questions, contact the Division of Industry and Consumer Education.
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