Medtronic announces Class I recall for certain implantable defibrillators

Due to a risk of low or no energy output during high voltage therapy, Medtronic and the FDA announced a Class I recall of certain Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) with Glassed Feedthrough.

The recalled products are listed below:

  • Cobalt XT, Cobalt, Crome ICDs and CRT-Ds
  • Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
  • Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs
  • Distribution Dates: October 13, 2017 to June 9, 2023

The recalled devices pose a risk of reducing energy shock, or giving no shock at all and may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, other serious injury, or even death.

According to Medtronic there are 28 incidents, 22 injuries and no deaths for this issue.

Medtronic sent out an Urgent Medical Device Correction Notice to consumers on May 10th, 2023.

If you are affected and want to know more information about this recall, head to the FDA consumer alert regarding this issue.

You are also encouraged to contact your local Medtronic representative, or call Technical Services at 1-800-929-4043.