Nearly 350,000 Medtronic Inplantable Defibrillators See Class I Recall

Medtronic’s recall of more than 348,000 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRT-D) has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death.

The affected devices, all glassed feedthrough models, may apply little to no electric charge when high voltage therapy is required to correct a cardiac arrhythmia. The safety issue stems from these products inappropriately activating a short circuit protection feature, the FDA said.

“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,” the FDA cautioned. “There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device.”

The massive recall was initiated on May 10. The FDA reported 28 incidents and 22 injuries, but no deaths related to the device.

Read the agency’s full announcement here.

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