The Class I recall — the most serious classification from the FDA — is due to the potential for reduced shock energy during high-voltage therapy for Cobalt and Crome ICDs and CRT-Ds, according to FDA data.
Some devices delivered only around 79% of the programmed energy, which Medtronic estimates has a 1% reduction on efficacy.
Medtronic had no reports of permanent harm or deaths due to the issue.
Medtronic is not recommending replacement of implanted devices. A software update is expected to fix the problem in new and existing implantations. Medtronic is asking hospitals to return certain non-implanted devices for inspection.
After receiving FDA approval and CE mark for the software update, Medtronic started rolling the code out for in-clinic reprogramming of implanted devices and pre-installation on newly manufactured devices this month.
“Medtronic has instructed physicians to set these devices at maximum energy output (40 joules); by programming to maximum output, the impact on the devices’ effectiveness is minimal (e.g., 99% efficacy to 98% efficacy) if the issue occurs,” the company said in an email today.
More information on the recall is available at Medtronic’s website.
Another Medtronic Class I recall of ICDS and CRT-Ds last year covered 239,171 devices for potential battery life problems related to more than 400 complaints regarding Medtronic’s Evera, Viva, Brava, Claria, Amplia, Compia and Visia devices.