Medtronic ICD recall 2023: All you need to know amid a spate of injuries 

The FDA is warning people about the recall of over 350,000 Medtronic ICD devices. Recalled by Medtronic, the "implantable cardioverter-defibrillators" and "cardiac resynchronization therapy defibrillators" are feared to produce low or no energy shocks during critical conditions.

Announced on July 18, 2023, the nationwide recall applies to almost all ICDs and CRT-Ds with a glassed feedthrough manufactured by the establishment after 2017.

The risks related to the recalled Medtronic ICD devices may range from serious injuries to death (Image via Medtronic)

The recall notice published on the FDA website informed users and professionals that,

“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.”

Additionally, the FDA alert cautioned users that,

“There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device.”

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The Medtronic ICD faces Class I recall

According to the recall notice published on the FDA website, the nationwide recall issued by Medtronic affects nearly 350,000 Medtronic ICD and CRT-Ds devices that may be in use nationwide.

The 'Class I recall' may cause the users to experience serious injuries and, in the worst scenarios, death. The federal agency has already received at least 28 reports of incidents and over 22 reports of injuries linked to the recalled devices. However, the agency has yet to report any deaths or fatalities caused by the faulty devices.

The federal agency stated that the recall specifically applies to Viva and Brava CRT-Ds, Primo MRI ICDs, Cobalt XT, Mirro MRI ICDs, Compia MRI, Visia AF, Cobalt, and Crome ICDs, Visia AF MRI, Claria MRI, Evera, Amplia MRI, CRT-Ds, and Evera MRI devices.

A May 10 Urgent Medical Device Correction Notice that was delivered to all users of the affected devices served as the establishment's previous warning to users. The users were warned against replacing the devices (prophylactically). The establishment also suggested the users' program,

“All high-voltage therapy pathways B>AX in all therapy zones.”

The recalled Medtronic ICDs and CRT-Ds are linked with over 28 incidents and 22 injuries (Image via Sundry Photography / iStock Editorial /Getty Images)

Medical professionals, on the other hand, were reminded of the importance of checking up on patients with AX>B programming in any high-voltage therapy sequences. The notification was meant to allow the professionals to provide follow-up care to allow the necessary reprogramming to occur without any problems.

Users, family members of the users, or professionals who may be affected by or related to the Medtronic ICD recall are advised to report faulty devices, adverse reactions, or quality problems to MedWatch. The federal agency can be contacted through the online form on the website or by calling 1-800-332-1088.

Individuals with other questions about the affected devices may contact their local Medtronic representative or Medtronic Technical Services at 1-800-929-4043.