FDA announces recall of nearly 88,000 implantable cardiac devices due to risk of serious injury or death
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.
Image courtesy of Medtronic.
ICDs and CRT-Ds should not be replaced if there have been no signs of an issue, according to a communication Medtronic sent out to customers. If necessary, the devices can be reprogrammed at a patient’s next scheduled in-clinic follow-up appointment. A software update has already been completed, and it will be pre-installed into all devices going forward.
How can SCP alerts associated with these reduced-energy electrical shocks be differentiated from legitimate cardiac issues? According to the FDA’s advisory, “If the delivered energy during the episode is ~79% of the programmed energy and the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero ohms, this is an indication of a second-phase SCP event and not a lead issue.”
In its communication to patients, Medtronic also emphasized that multiple device functions—including pacing, sensing and episode detection—are not impacted by this issue.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.