The recall affects cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators that were “sent through a manufacturing sequence that introduced the potential for internal arcing during high-voltage charging, leading to the immediate and permanent loss of device functionality,” according to a January doctors letter from quality & regulatory VP Tim Samsel.
The issue led to a single instance in which an implanted device failed, in which external defibrillation was required to rescue the patient. The affected CRT-Ds are from Fridley, Minn.-based Medtronic’s Amplia, Claria, Compia and Viva lines. The ICDs involved in the recall are from the Evera and Visia lines.
“Due to the nature of this issue, it is not possible to identify which of these 48 devices may fail or when they may fail. Further, we cannot predict how many high-voltage charges can occur prior to a potential failure,” Samsel wrote.