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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.

In June, Medtronic issued an urgent field safety notice in Europe warning of the same problem.

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.

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular, Featured, Implants, News Well, Recalls, Regulatory/Compliance, Structural Heart Tagged With: FDA, Medtronic

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