Thursday, July 27, 2023

Medtronic recalls defibrillators - ICDs and CRT-Ds

Medtronic is recalling all ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough, as they may deliver low or no energy output when high voltage therapy is needed due to inappropriate activation of the Short Circuit Protection (SCP) feature.

The products are the Cobalt XT, Cobalt, Crome ICDs, Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds and the Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI and Mirro MRI ICDs.
The recall involves about 348,616 defibrillators distributed in the United States from Oct. 13, 2017, to June 9, 2023.

A reduced-energy shock, or no shock at all, may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or death. There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device.

Medtronic reports 28 incidents, 22 injuries, and no deaths for this issue.

Who May be Affected?
  • People implanted with affected ICDs and CRT-Ds.
  • Health care providers who implant and manage patients with ICDs and CRT-Ds.