Medtronic Recalls 48 Individual ICDs and CRT-D Units
Medtronic Recalls 48 Individual ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery
On February 26, the Food and Drug Administration (FDA) announced a recall of 48 individual Medtronic ICDs and CRT-Ds , identified by the devices' serial numbers. For these 48 individual units, the Class I recall recommends that the physician and the patient strongly consider prophylactic device replacement for patients who have been implanted with one of the affected devices. HRS has communicated with Medtronic to verify that the problem has been addressed. On January 22, 2018, Medtronic notified all physicians whose patients had the devices.
Medtronic has identified a defect in the manufacturing process that caused an out of specification gas mixture inside the device that may prevent the device from delivering an electrical shock. One patient with an affected ICD experienced sudden cardiac arrest and was revived via an external defibrillator. Medtronic determined that 48 individual devices made in a single manufacturing location and only distributed in the United States were affected.
Customers who have questions or need additional information or support regarding this recall should contact Medtronic Technical Services at 800-723-4636. Patients can contact Medtronic Patient Services at 800-551-5544 (Monday-Friday, 8am-5pm Central Time).