Medtronic initiates recall for defibrillators due to defect

Medtronic defibrillator recall overview: 

• Who: Medtronic recalled more than 348,000 defibrillators. 
• Why: The recalled defibrillators may deliver low or no energy output when high-voltage therapy is needed. 
• Where: The Medtronic defibrillator recall is active in the United States.

Medtronic has issued a recall of more than 348,000 defibrillator products, as they may deliver low or no energy output when high-voltage therapy is needed; there have been at least 22 injuries so far. 

The U.S. Food & Drug Administration (FDA) website published the Class 1 recall, the most serious type of recall, July 18. 

“Use of these devices may cause serious injuries or death,” the Medtronic defibrillator recall states. 

The recall applies to certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with glassed feedthrough made under different product names. The exact recalled defibrillators, product names and codes can be seen on the FDA’s website. 

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. 

Faulty defibrillators can lead to cardiac arrest or death, recall states

Medtronic’s ICDs and CRT-Ds are implantable cardiac devices intended to monitor and regulate heart rate and rhythm, the recall notice states. They automatically detect and treat life-threatening irregular heartbeats by producing an electric shock to restore a normal heartbeat.

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

“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 recall states. 

Medtronic has reported 28 incidents, 22 injuries and no deaths in relation to the issue. The company is not facing legal action over the recall, but Top Class Actions follows recalls closely as they sometimes lead to class action lawsuits.

People implanted with the affected ICDs and CRT-Ds should see their health care providers immediately. The health care providers should program the devices to minimize risk using the specific advice found in the recall notice. 

In 2020, Medtronic agreed to a $26 million settlement in a Candadian class action lawsuit alleging Medtronic Sprint Fidelis Leads were prone to fracturing, potentially shocking patients and requiring replacement.

Are you affected by this defibrillator recall? Let us know in the comments! 

Read About More Class Action Lawsuits & Class Action Settlements:

• Bayer files $12M lawsuit against former supplier over benzene contamination
• Patients who received faulty Exactech knee and hip devices can seek compensation
• Amazon, Theragun file lawsuit against counterfeit massage devices on platform
• Theraflu class action claims Emergen-C convenience pack misleads consumers