FDA designates recall of two intra-aortic balloon pumps as class 1
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The FDA has designated Arrow International’s recall of two intra-aortic balloon pumps as a class 1 recall, the most serious kind.
The recall affects 2,123 intra-aortic balloon pumps (AutoCAT 2 and AC3 Optimus) manufactured and distributed between Aug. 1, 2014, and May 1, 2020, according to a safety alert from the agency
The intra-aortic balloon pumps are used in patients undergoing cardiac and noncardiac surgery, and for those with ACS or HF complications.
The pumps were recalled due to a part within the motor driver potentially charring, breaking and discoloring the motor connector wires. This may result in pump alarms for “High Baseline” and “System Error 3,” in addition to sudden stoppage of the intra-aortic balloon pump without an alarm. The interruption may lead to serious patient harm including death and serious organ damage, according to the alert.
Issues related to pump alarms and sudden stoppage have led to 30 complaints, although no deaths or injuries associated with these complaints were reported.
Arrow International distributed a letter May 20 alerting customers to check their inventory for affected models, ensure that backup intra-aortic balloon pumps are available and to use alternative therapy or a backup balloon pump if either alarm is displayed, according to the alert. The letter also informs customers not to use the devices for air or ground transport between medical facilities.
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