FDA announces recall of intra-aortic balloon pumps due to risk of cardiac arrest, stroke or death
The U.S. Food and Drug Administration (FDA) has announced that Arrow International, a subsidiary of Teleflex, is recalling more than 2,000 intra-aortic balloon pumps (IABPs) due to significant battery issues. This is a Class I recall, meaning “the use of these devices may cause serious injuries or death.”
There have been 241 complaints, and 135 reported pump stops, related to this issue. No deaths have been reported.
The recall includes 2,132 Arrow AutoCAT 2 and AC3 IABPs distributed from July 1 to Sept. 30, 2022. A fully charged battery for one of these devices is expected to last 90 minutes, but users are experiencing much shorter run times. Problems have also been reported with the warnings designed to alert a user when there are 20, 10 or five minutes of battery power remaining.
“If the pump’s battery depletes, the pump may stop when operated on battery power only,” according to the FDA’s advisory. “Sudden stopping of the pump’s mechanical support to the patient’s heart can lead to cardiac arrest, stroke or death.”
Teleflex warned customers of this issue in October, recommending that they immediately connect their device to an AC power source if the pump battery fails while being used. If AC power is not immediately available, the patient should be transferred to a different device altogether.
Teleflex also recommended that users keep a backup IABP “fully charged and readily available.” If the battery issue causes pumping to stop for longer than 15 to 30 minutes, users should “manually inflate and deflate the intra-aortic balloon several times per hour” and “consider removing the balloon.”
Users have also been urged to keep these devices plugged in as much as possible—especially when not in use—and perform tests every 12 months to ensure the batteries are working.
“Do not transport patients with affected intra-aortic balloon pump devices until a battery load test is performed, if one has not been completed in the last 12 months,” according to the advisory.
Read the full announcement on the FDA’s website here.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.