Medtronic has issued a Class I recall for certain implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds). The US Food and Drug Administration (FDA) classifies Class I recalls as the most serious type, as using the affected devices may lead to severe injuries or even fatalities.

The recall specifically affects the following Medtronic products manufactured after 2017, all equipped with a glassed feedthrough:

  • 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

The reason behind the recall lies in the possibility of these devices delivering low or no energy output when high voltage therapy is required. This issue arises due to the inappropriate activation of the Short Circuit Protection (SCP) feature, mainly affecting devices with a glassed feedthrough configured to deliver therapy in the AX>B delivered pathway.

For patients relying on these devices, the consequences of receiving a reduced-energy shock or no shock at all during a life-threatening arrhythmia can be dire. Such a malfunction may fail to correct the irregular heartbeat, leading to cardiac arrest, serious injuries, or even death. Additionally, patients with affected devices may face increased risks during any subsequent surgical procedures required to remove and replace the device.

Incidents and Reporting

According to Medtronic, there have been 28 incidents related to this issue, resulting in 22 injuries. Thankfully, there have been no reported deaths associated with this problem. Nevertheless, the potential for serious harm is evident, and immediate action is necessary.

Who is Affected and Required Actions

The recall directly impacts individuals implanted with the affected ICDs and CRT-Ds, along with healthcare providers responsible for implanting and managing these devices. In response to the recall, Medtronic issued an Urgent Medical Device Correction Notice to its customers, outlining the following required actions:

  1. Prophylactic replacement of devices for this issue is not recommended.
  2. Program all high voltage therapy pathways B>AX in all therapy zones to minimize the risk of this issue.
  3. Prioritize reprogramming patients with a history of high voltage therapy and Rx1 programmed AX>B.
  4. Encourage patients with AX>B programming in any high voltage therapy sequence to attend their next scheduled follow-up in-clinic for device reprogramming.
  5. Remotely monitor patients following normal clinical protocols.
  6. Observing certain indications such as reduced- or no-energy high voltage therapy and a persistent drop in pacing lead impedance, healthcare providers should take appropriate measures.

Contact Information and Additional Resources

Patients and healthcare providers with any questions regarding the recall should promptly reach out to their Medtronic local representative or Technical Services at 1-800-929-4043.

For further information and reporting any adverse reactions or quality problems related to these devices, healthcare professionals and consumers may contact MedWatch: The FDA Safety Information and Adverse Event Reporting Program. They can use the online form or call 1-800-332-1088, and information on mailing or faxing the form is also available.