Arrow Worldwide is recalling its AutoCat 2 and AC3 Optimus intra-aortic balloon pump (IABP) collection attributable to the alternative of motor connector wires to give plan.
Both units possess an MForce motor driver which will damage, char, and discolor the motor connector wires, fixed with the company. This could lead to pump alarms for “Draw Error 3” and “High Baseline” supplied on the camouflage of the IABP.
“Furthermore, the IABP could without warning pause, even with out an dismay. This could suggested crucial affected person injure along side crucial organ damage and loss of life,” the July 2 recall stare warns.
The US Meals and Drug Administration has labeled this as a class I recall, the famous form, attributable to the alternative of crucial injure or loss of life.
Arrow Worldwide has obtained 30 complaints about the units. No accidents or deaths were reported, fixed with the awareness.
A total of 2123 units are being recalled. They were dispensed between March 15, 2018 and May per chance most seemingly per chance most seemingly simply 1, 2020. Tiny print on the serial numbers of the affected units could well be stumbled on right here.
The AutoCat 2 and AC3 Optimus IABPs are veteran for patients present process cardiac and noncardiac surgical design and to treat patients with acute coronary syndrome or complications from heart failure.
Arrow Worldwide despatched an pressing scientific instrument correction letter to customers May per chance most seemingly per chance most seemingly simply 20 with recommendations and actions which may be featured within the recall stare.
Clients with questions can contact Teleflex at 1-855-419-8507 or [email protected].
Healthcare professionals and patrons can file damaging reactions or quality complications they skills using the units to the FDA’s MedWatch program.
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