Some of Medtronic’s ICDs & CRT-Ds Face Class I Recall

About 348,616 of Medtronic’s ICDs and CRT-Ds are facing a Class I recall, the most serious type of recall.

The recall impacts 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 issue is more likely to occur for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway, according to a notice from FDA.

In a notice regarding the recall, FDA noted that 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. 

In May, the Dublin-based company issued an Urgent Medical Device Correction Notice to customers.

“Medtronic provided physicians with comprehensive patient management recommendations in the communication,” the company told MD+DI via email. “We have recommended that physicians non-invasively reprogram these devices to reduce the risk for this issue.”

Here are the names of the products that have been impacted by the recalls.

Product Names: 

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