Sam Brusco, Associate Editor07.18.23
The U.S. Food and Drug Administration (FDA) has deemed Medtronic’s May 10 recall of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured after 2017 as Class I.
The recall covers the following devices distributed between October 13, 2017 and June 9, 2023:
Medtronic recalled all the ICDs and CRT-Ds with a glass feedthrough because they might deliver low or no energy output when high voltage therapy is required. This is due to inappropriate activation of the short circuit protection (SCP) feature, according to the FDA. The problem is more likely for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.
A reduced-energy shock (or no shock at all) could fail to correct a life-threatening arrhythmia, leading to possible cardiac arrest, other serious injury, or death. Additional risks of harm can occur if a patient needs further surgical procedures to remove and replace the device.
Medtronic reported to the FDA that there were 28 incidents, 22 injuries, and no deaths as of yet related to this issue.
In its Urgent Medical Device Correction Notice issued May 10, Medtronic advised not to prophylactically replace devices for the issue. The company also urged programming all high voltage therapy pathways B>AX in all therapy zones and prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
Patients with AX>B programming in any high voltage therapy sequence were encouraged to attend their next scheduled follow-up in-clinic for device reprogramming. Physicians were advised to remotely monitor patients following normal clinical protocol.
The recall covers the following devices distributed between October 13, 2017 and June 9, 2023:
- 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
Medtronic recalled all the ICDs and CRT-Ds with a glass feedthrough because they might deliver low or no energy output when high voltage therapy is required. This is due to inappropriate activation of the short circuit protection (SCP) feature, according to the FDA. The problem is more likely for devices with a glassed feedthrough that are configured to deliver therapy in the AX>B delivered pathway.
A reduced-energy shock (or no shock at all) could fail to correct a life-threatening arrhythmia, leading to possible cardiac arrest, other serious injury, or death. Additional risks of harm can occur if a patient needs further surgical procedures to remove and replace the device.
Medtronic reported to the FDA that there were 28 incidents, 22 injuries, and no deaths as of yet related to this issue.
In its Urgent Medical Device Correction Notice issued May 10, Medtronic advised not to prophylactically replace devices for the issue. The company also urged programming all high voltage therapy pathways B>AX in all therapy zones and prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
Patients with AX>B programming in any high voltage therapy sequence were encouraged to attend their next scheduled follow-up in-clinic for device reprogramming. Physicians were advised to remotely monitor patients following normal clinical protocol.