The U.S. Food and Drug Administration (FDA) has announced a Class I recall, the most serious type, for nearly 350,000 Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The products include Cobalt XT, Cobalt, Crome ICDs and CRT-Ds, Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds, and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs. These devices, distributed from October 13, 2017, to June 9, 2023, are used to monitor and regulate heart rate and rhythm, detecting and treating life-threatening arrhythmias by producing an electric shock to restore a normal heartbeat.
The recall was initiated on May 10, 2023, due to a potential malfunction that could lead to low or no energy output when high-voltage therapy is needed. The issue is more likely to occur with devices that have a glassed feedthrough manufactured after 2017 and configured to deliver therapy in the AX>B delivered pathway. This malfunction can result in a reduced-energy shock or no shock at all, failing to correct a life-threatening arrhythmia and potentially leading to cardiac arrest, serious injury, or death. Additional risks of harm may occur if a patient requires surgical procedures to remove and replace the device.
The FDA noted:
Medtronic issued an URGENT MEDICAL DEVICE CORRECTION NOTICE to its consignees on 05/10/2023 by UPS 2-day delivery or email. Consignees are asked to forward this notification to those who need to be aware within the organization and to any location which the devices have been distributed. The notice explained the problem and the risk and requested the following patient management recommendations:
- Prophylactic device replacement is NOT recommended.
- Program all HV therapy pathways B>AX in all therapy zones to minimize the risk for this issue.
- Prioritize reprogramming patients who have both a history of HV therapy and Rx1 programmed AX>B.
- For remaining patients with AX>B programming in any HV therapy sequence, schedule (with appropriate discretion) the next follow-up for in-clinic reprogramming to minimize potential for reduced- or no-energy HV therapies to occur. – 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 HV 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.
So far, Medtronic has reported 28 incidents and 22 injuries due to this issue. Individuals with the affected ICDs and CRT-Ds, as well as healthcare providers who implant and manage these devices, are urged to take note of this recall.
In response, Medtronic issued an Urgent Medical Device Correction Notice to customers with recommended actions. These include not prophylactically replacing devices, programming high voltage therapy pathways B>AX in all therapy zones, prioritizing reprogramming for patients with a history of high voltage therapy, and ensuring in-clinic follow-ups for reprogramming. Medtronic also advises remote monitoring of patients following standard clinical protocols.
In the event your Medtronic ICD or CRT-D malfunctions, consider filing a product liability lawsuit against the manufacturer. Holding a medical technology manufacturer accountable for a dangerous defect can be an uphill battle. The experienced and aggressive medical device attorneys at Spagnoletti Law Firm can help you understand your rights if you or a loved one sustained an injury as a result of a medical device. There are strict and short time limits on bringing claims, so please contact us online or call 713-804-9306 or 877-678-5864 to learn more about your rights.