The U.S. Food and Drug Administration (FDA) has issued a Class I recall, the most serious type of recall, for certain Medtronic implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds).
This recall is due to a potential issue with the devices’ glassed feedthrough, which may cause low or no energy output during high voltage therapy. The use of these devices may lead to serious injuries or even death. In this article, we will explore the details of the recalled products, the reason for the recall, the potential risks, and the actions that affected individuals and healthcare providers should take.
Recalled Products
The affected products include the following:
- Cobalt XT, Cobalt, Crome ICDs
- Claria MRI, Amplia MRI, Compia MRI, Viva, Brava CRT-Ds
- Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI, Mirro MRI ICDs
These ICDs and CRT-Ds were distributed between October 13, 2017, and June 9, 2023, and a total of 348,616 devices have been recalled in the U.S.
Device Use
Medtronic’s ICDs and CRT-Ds are implantable cardiac devices designed to monitor and regulate heart rate and rhythm. They are crucial for patients at risk of life-threatening irregular heartbeats (arrhythmia). The devices can automatically detect such abnormalities and deliver electric shocks (cardioversion or defibrillation) to restore a normal heartbeat. Additionally, some devices can provide cardiac resynchronization therapy to treat heart failure.
Reason for Recall
Medtronic initiated the recall of ICDs and CRT-Ds with a glassed feedthrough manufactured after 2017. The recall stems from a concern that these devices may deliver low or no energy output when high voltage therapy is required due to the inappropriate activation of the Short Circuit Protection (SCP) feature. The issue is more likely to occur in devices with a glassed feedthrough configured to deliver therapy in the AX>B delivered pathway.
Consequences of reduced-energy or no shock therapy during a life-threatening arrhythmia could be severe, leading to cardiac arrest, serious injuries, or even fatalities. Furthermore, if a patient with an affected device requires additional surgical procedures to remove and replace the device, there are additional risks of harm.
Medtronic has reported 28 incidents related to this issue, resulting in 22 injuries, but thankfully, no deaths have been reported so far.
Who May be Affected
Recommended Actions
Medtronic issued an Urgent Medical Device Correction Notice to customers on May 10, 2023. The notice provides several required actions related to the software issue causing the recall:
- Do not replace devices prophylactically 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.
Healthcare providers should contact Medtronic Technical Services (1-800-929-4043) or their local representatives if they observe certain indications that may point to a device or lead-related issue, such as reduced- or no-energy high voltage therapy displayed in Episode Text or a significant drop in RA, RV, and LV pacing lead impedance measurements.
Conclusion
The Medtronic recall of certain ICDs and CRT-Ds with glassed feedthrough is a Class I recall due to the potential risk of low or no energy output during high voltage therapy, which could lead to serious harm or death. Patients implanted with the affected devices and healthcare providers involved in their management should carefully follow the recommended actions provided by Medtronic to minimize the risks associated with this issue. For any inquiries or further information, customers may contact their Medtronic local representative or Technical Services at 1-800-929-4043.
reference link:https://www.fda.gov/medical-devices/medical-device-recalls/medtronic-recalls-implantable-cardioverter-defibrillators-icds-and-cardiac-resynchronization-therapy
