The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling nearly 350,000 implantable cardiac devices due to continued issues with their ability to deliver high voltage therapy when necessary.
“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,” according to an advisory on the FDA website. “There are additional risks of harm if a patient with one of these devices needs additional surgical procedures to remove and replace the device.”
The recall includes all implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) with a glassed feedthrough manufactured after 2017. The FDA has categorized this as a Class I recall, meaning the use of these devices “may cause serious injuries or death.”
Specific products included in the recall are the Cobalt XT, Cobalt and Crome ICDs and CRT-Ds; Claria MRI, Amplia MRI, Compia MRI, Viva and Brava CRT-Ds; and Visia AF, Visia AF MRI, Evera, Evera MRI, Primo MRI and Mirro MRI ICDs.
There have been 28 incidents and 22 injuries so far due to this ongoing issue. No deaths have been reported. Medtronic had to recall 87,709 devices due to a similar issue back in August 2022.
On May 10, Medtronic sent an Urgent Medical Device Correction Notice to all customers impacted by the recall with detailed instructions. Customers were warned not to “prophylactically replace devices” and advised to program “all high-voltage therapy pathways B>AX in all therapy zones.” The company also highlighted the importance of seeing any patients with AX>B programming in any high-voltage therapy sequences for follow-up care so that reprogramming can occur as necessary.
As always, adverse reactions and other quality issues can be reported to the FDA through the MedWatch Online Voluntary Reporting Form.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.