Medtronic recalls nearly 350,000 defibrillators for risk of reduced shock

The FDA has identified a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.;Recalled Product 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.

Medtronic is recalling all 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. 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. Medtronic reports 28 incidents, 22 injuries, and no deaths for this issue.

On May 10, 2023, Medtronic issued an Urgent Medical Device Correction Notice to customers. The communication provided the following required actions for software issue related to this recall: i. Do not prophylactically replace devices for this issue. ii. Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue. iii. Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B. Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming. iv. Remotely monitor patients following normal clinical protocol. Contact Medtronic Technical Services (1-800-929-4043) or your local representative if one of the following is observed as these may be an indication of either a device or lead-related issue:i. reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway). ii. A persistent drop of approximately 50% in RA, RV and LV pacing lead impedance measurements as this may be an indication of increased potential for a future reduced- or no-energy therapy.