The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling 87,709 implantable cardiac devices due to the risk of a malfunction that could result in serious injury or death.
Devices included in the recall are Medtronic’s Cobalt XT, Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). They were distributed to customers from Feb. 3, 2020, to the present day.
The recall was initiated after the company became aware of short circuit protection (SCP) alerts that were causing the devices to send reduced-energy electric shocks.
“A reduced-energy electrical shock may fail to correct an irregular heartbeat (arrythmia) or may cause an irregular heartbeat,” according to the FDA’s advisory. “The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death.”
This is a Class I recall, which is the agency’s most serious classification. There have been 27 customer complaints about the issue so far. No injuries or deaths have been reported.
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SOURCE: Cardiovascular Business