Medtronic has recalled Cobalt XT, Cobalt, and Crome implantable cardioverter defibrillators (ICDs) and resynchronization therapy defibrillators (CRT-Ds) after reports that some devices delivered reduced-energy electric shocks, triggering short-circuit protection (SCP) alerts.
A reduced-energy electrical shock may fail to correct an arrhythmia or may cause an arrhythmia.
“The harms associated with a reduced-energy electric shock or an inaccurate response to an SCP alert may cause serious injury or death,” the US Food and Drug Administration (FDA) says in an alert posted on its website.
The agency has identified this as a class I recall, the most serious type, because of the potential for serious injury or death.
To date, there have been 27 complaints but no injuries or deaths associated with this problem.
The recall covers 87,709 devices distributed after February 3, 2020. Links to the model numbers for the recalled devices are noted in the FDA alert.
Medtronic has sent a letter to customers regarding this recall.
The company advises against prophylactic device removal, and says patients should be remotely monitored following normal clinical protocol follow-up.
They say health providers should only consider replacing devices after observing and confirming a reduced-energy event with a Medtronic representative.
“If the delivered energy during the episode is roughly 79% of the programmed energy AND the SCP alert indicates an RV Defib Lead impedance alert reporting exactly zero (0) ohms, this is an indication of a second-phase SCP event and not a lead issue,” the alert states.
If this happens, customers should contact Medtronic technical services (1-800-723-4636) or their local representative.
Medtronic says it has started to deploy a software update to correct the issue in affected devices that have already been implanted. The update, to be preinstalled in new devices starting this month, it says, aims to ensure that full-shock energy is delivered in the presence of a secondary, low-level current pathway in the high-voltage circuitry.
The company notes that the following device functions are not affected after an SCP alert: pacing, sensing, episode detection, antitachycardia pacing therapies, high-voltage charging, battery longevity, and Bluetooth telemetry.