The FDA designated a recall of some Medtronic
(NYSE: MDT)
defibrillators as Class I, the most serious kind.
Medtronic’s recall affects implantable cardiac defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). Affected products include the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds, plus the Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds. The recall also affects the Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI and Mirro MRI ICDs.
These devices monitor and regulate heart rate and rhythm. They automatically detect and treat life-threatening arrhythmias with electric shock (cardioversion or defibrillation) to restore a normal heartbeat. Some devices also provide cardiac resynchronization therapy to treat heart failure.
Why Medtronic recalled the devices
Medtronic recalled the ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough. These specific devices may deliver low or no energy output when high-voltage therapy is needed. This occurs due to the inappropriate activation of the Short Circuit Protection (SCP) feature.
According to an FDA notice, the issue becomes more likely for devices with a glassed feedthrough, configured to deliver therapy in the AX>B pathway. A reduced energy shock or no shock at all may fail to correct a life-threatening arrhythmia. This could lead to cardiac arrest, other serious injury or death. Additional risks of harm occur if a patient with one of these devices requires additional surgical procedures to remove and replace the device.
Medtronic reports 28 incidents, 22 injuries and no deaths for the issue. The company recalled 348,616 devices in the U.S. since initiating its recall on May 10, 2023. Affected devices were distributed between Oct. 13, 2017, and June 9, 2023.
The company issued an urgent medical device correction notice to customers on May 10. Instructions included telling customers not to prophylactically replace devices for the issue. Users should program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
They should also prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B. Customers ought to encourage patients with AX>B programming in any high-voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming. They should also remotely monitor patients following normal clinical protocol.