FDA designates intra-aortic balloon pump recall as class I
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Arrow International announced it is recalling its intra-aortic balloon pumps after receiving complaints about shorter than expected battery power.
The FDA identified the recall of these devices (Arrow AutoCAT 2 and AC3) as class I, the most serious type of recall.
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A fully charged battery should last 90 minutes; however, multiple users have reported shorter battery life, according to a press release from the FDA.
In addition, the battery life warnings — designed to sound at 20, 10 and 5 minutes of power remaining — are inaccurate, according to the release.
If operated on battery power alone, the pump may suddenly stop mechanical support to the patient’s heart, potentially leading to cardiac arrest, stroke or death, according to the release.
The recall affects 2,132 devices distributed between July 1, 2022 and Sept. 30, 2022.
There have been 241 complaints reported with 135 instances of the pumps stopping. No deaths have been reported related to this issue.
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