Medtronic Extends Voluntary Recall to Include 752 ICDs and CRT-D Units Due to Lack of Electrical Shock Delivery

Medtronic recommends that prophylactic device replacement be considered only for patients whose clinical history indicates prior need for high-voltage therapy, and/or those who are pacemaker-dependent. Medtronic has contacted those healthcare professionals who have one or more patients implanted with an affected device. The communication also includes a list of the affected models.

This notification extends the Food and Drug Administration (FDA) recall on February 26, 2018 of 48 Medtronic devices that were identified to have a defect in the manufacturing process that could lead to an out-of-specification internal gas environment. This may introduce a risk for internal arcing during high-voltage charging, resulting in immediate and permanent loss of device functionality, including pacing and high-voltage therapy.

Within this lower-risk subset of 752 devices, if the device delivered the maximum number of shocks until battery depletion, Medtronic estimates 0.5% of these devices would experience arcing during high-voltage charging, with failure occurring within the first 2 high-voltage charges in 0.18% of the devices.