FDA designates recall of ICD, CRT devices as class I
Click Here to Manage Email Alerts
The FDA announced Medtronic has issued a recall of its implantable cardioverter defibrillators and cardiac resynchronization therapy devices due to a short circuit protection alert resulting in reduced-energy electric shock delivery.
A reduced-energy shock may fail to correct an arrythmia or cause an arrhythmia, according to a press release from the agency.
The FDA has identified this recall as class I, the most serious type of recall.
There have been 27 complaints related to these devices (Cobalt XT, Cobalt, Crome ICD and Crome CRT), and no injuries or deaths associated with this issue, according to the release.
The recall includes 87,709 devices distributed from Feb. 3, 2020 to present.
According to the release, the company issued a communication to customers in June 2022 and provided the following recommendations:
- Do not prophylactically replace devices for this issue.
- Remotely monitor patients following routine follow-up.
- Encourage patients to attend their next follow-up for device reprogramming, if necessary.
The company added that cases where the delivered shock is approximately 79% of the programmed energy and the short circuit protection alert indicates a right ventricular defibrillator lead impedance alert of exactly 0 ohms is an indication of a second-phase short circuit protection event and not a lead issue.
Device functions that are not impacted after a short circuit protection alert include pacing, sensing, episode detection, antitachycardia pacing therapies, high voltage charging, battery longevity and Bluetooth telemetry, according to the release.
The company received FDA approval and CE Mark for a software update to help mitigate this issue and began deployment of the update into already-implanted devices via in-clinic device checks in August 2022. Newly manufactured devices will have the update pre-installed starting in August.
Editor’s Note: This article was updated on August 19, 2022 to add information provided by Medtronic.
Click Here to Manage Email Alerts