FDA has issued a Class I recall of some Medtronic pacemakers manufactured between July 13, 2013, and August 8, 2017. Class I is the most serious type of recall, signifying that the devices may cause serious injuries or death.
The recall affects the company’s Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds), which provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. A defect in the manufacturing process causes an out-of-specification gas mixture inside the device and may prevent it from delivering the electrical shock needed to pace a patient’s heartbeat or revive a patient in cardiac arrest, said FDA on its website. Forty-eight patients in the United States are affected by this recall.
A notice from Medtronic said that it had confirmed one implanted device failure resulting in a loss of high-voltage therapy related to this issue. The patient was rescued by means of external defibrillation. “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,” wrote Medtronic in an advisory letter posted on its website. Medtronic sent notices to patients in January, but the FDA announcement wasn’t made public until this week.
FDA recommends to affected customers that they consider a “prophylactic device replacement.” They should also contact their Medtronic sales representative for terms and conditions for device warranties.
Medtronic has said that it will offer a supplemental device warranty for affected devices.