July 18, 2023 — The U.S. Food and Drug Administration (FDA) has issued a Class I recall on the Medtronic ICDs and CRT-Ds, manufactured after 2017, with a glassed feedthrough as they may deliver low or no energy output when needed for high voltage therapy. The issue is more likely to occur for devices with a glassed feedthrough configured to delivery therapy in the AX>B pathway.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
- 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
- Product Codes: See Medical Device Recall Database entries.
- Distribution Dates: October 13, 2017 to June 9, 2023
- Devices Recalled in the U.S.: 348,616
- Date Initiated by Firm: May 10, 2023
Medtronic’s implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) are implantable cardiac devices that are intended to monitor and regulate heart rate and rhythm.
These devices automatically detect and treat life-threatening irregular heartbeats (arrythmia) by producing an electric shock (cardioversion or defibrillation) to restore a normal heartbeat. Some devices can also provide cardiac resynchronization therapyExternal Link Disclaimer to treat heart failure.
Reason for Recall
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.
Who May be Affected
- People implanted with affected ICDs and CRT-Ds.
- Health care providers who implant and manage patients with ICDs and CRT-Ds.
What to Do
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:
- Do not prophylactically replace devices for this issue.
- Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
- 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.
- 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:
- Reduced- or no-energy high voltage therapy is displayed in Episode Text (regardless of programmed pathway)
- 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.
- Please complete the confirmation form enclosed with the letter and email it to [email protected] to confirm receipt.
Customers with questions about this recall should contact their Medtronic local representative or Technical Services at 1-800-929-4043.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using the online form or call 1-800-332-1088 for more information on how to mail or fax the form.