Dive Brief:
- Medtronic is recalling 348,616 implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) manufactured after July 2017 because the devices may deliver a reduced-energy shock, or no shock at all, when therapy is needed, the U.S. Food and Drug Administration said Tuesday.
- The implantable devices may fail to correct a life-threatening arrhythmia, which can lead to cardiac arrest, serious injury, or death due to the reduced energy output, the FDA said.
- Medtronic, which communicated the problem to physicians in May, reported 28 incidents, 22 injuries and no deaths related to the Class 1 recall. There is an additional risk of harm if a patient needs additional surgery to remove and replace the device, the agency said.
Dive Insight:
The devices are designed to automatically detect and treat life-threatening irregular heartbeats by delivering an electric shock to restore a normal heart rhythm. Some also provide cardiac resynchronization to treat heart failure.
The recall comes a year after the company recalled more than 20,000 ICDs in the U.S. for a similar issue affecting the delivery of shock energy during high-voltage therapy, and two years after it recalled 240,000 defibrillators because of the potential for a rapid decrease in battery life.
Earlier recalls of Medtronic ICDs prompted the FDA in 2018 to issue warning letters to company plants in Minnesota and Puerto Rico.
The latest recall covers all Medtronic ICDs and CRT-Ds made after 2017 that have a glassed feedthrough component. The recalled products include Cobalt, Crome, Claria, Amplia, Compia, Viva, Brava, Visia, Evera, Primo and Mirro models, distributed in the U.S. between Oct. 13, 2017 and June 9, 2023. Medtronic identified the issue as part of a routine product analysis, the FDA said.
The company has instructed healthcare providers to reprogram the devices to change certain configurations and advised against prophylactically removing the implants.
“Medtronic provided physicians with comprehensive patient management recommendations in the communication. We have recommended that physicians non-invasively reprogram these devices to reduce the risk for this issue,” a Medtronic spokesperson said in an emailed statement.
J.P. Morgan analysts, in a research note, wrote that they see no material impact to Medtronic’s business from the recall. “With the current reprogramming recommendations, the ICDs and CRT-Ds remain available for continued implants,” the analysts said.