The FDA announced on Feb. 26 a Class I recall for nine of Medtronic’s cardiac resynchronization therapy with defibrillation (CRT-D) devices and 12 of its implantable cardioverter-defibrillators (ICDs).
Due to a manufacturing defect, a gas mixture can enter the devices and hamper their ability to provide shock therapy. A delay or inability of the devices to deliver a shock to the patient could result in serious injury or death, the FDA warned.
Medtronic first informed its customers of the flaw on Jan. 22 and suggested they consider prophylactic device replacement, which will be covered under a supplemental warranty.
The affected units were manufactured from July 13, 2013, to August 8, 2017. Devices in the recall include the Evera and Visia lines of ICDs, as well as the Amplia, Claria, Compia and Viva CRT-Ds.