FDA classifies Medtronic ICD, CRT-D recall due to shortened battery life as serious
The FDA announced that it has designated Medtronic’s recall of implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators as class 1, the most serious kind.
According to a press release from the agency, Medtronic recalled its Evera and Visia brands of ICDs and its Viva, Brava, Claria, Amplia and Compia brands of CRT-Ds “due to an unexpected and rapid decrease in battery life.”
The recall covered 239,171 devices distributed between Aug. 31, 2012, and May 9, 2018, according to the release.
“The decrease in battery life is caused by a short circuit and will cause some devices to produce a ‘recommended replacement time’ (first warning that the battery is low) earlier than expected. Some devices may progress from ‘recommended replacement time’ to full battery depletion within as little as 1 day,” the agency wrote in the release. “If the user does not respond to the first warning, the device may stop functioning. The likelihood that this issue will occur is constant after approximately 3 years of device use.”
So far, there have been 444 complaints and 264 medical device reports about the devices and 18 patients experienced bradycardia or HF symptoms, but there have been no deaths related to the devices, according to the agency.
The agency wrote that Medtronic’s recall notice advised that patients should continue regular follow-up and that the CareLink home monitoring system and the wireless low battery voltage CareAlert should be used when possible, but the device should be replaced promptly if unexpected “recommended replacement time” is observed.
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