Arrow International is recalling its AutoCat 2 and AC3 Optimus intra-aortic balloon pump (IABP) series because of the potential for motor connector wires to break down.
Both devices contain an MForce motor driver that may break, char, and discolor the motor connector wires, according to the company. This may lead to pump alarms for “System Error 3” and “High Baseline” presented on the screen of the IABP.
“Furthermore, the IABP may suddenly stop, even without an alarm. This may cause serious patient harm including serious organ damage and death,” the July 2 recall notice warns.
The US Food and Drug Administration has classified this as a class I recall, the most serious type, because of the potential for serious injury or death.
Arrow International has received 30 complaints about the devices. No injuries or deaths have been reported, according to the notice.
A total of 2123 devices are being recalled. They were distributed between March 15, 2018 and May 1, 2020. Details on the serial numbers of the affected devices can be found here.
The AutoCat 2 and AC3 Optimus IABPs are used for patients undergoing cardiac and noncardiac surgery and to treat patients with acute coronary syndrome or complications from heart failure.
Arrow International sent an urgent medical device correction letter to customers May 20 with recommendations and actions that are featured in the recall notice.
Customers with questions can contact Teleflex at 1-855-419-8507 or recalls@teleflex.com.
Healthcare professionals and consumers can report adverse reactions or quality problems they experience using the devices to the FDA’s MedWatch program.
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