Medtronic Extends Voluntary Recall to Include 752 ICDs and ... | 合法醫療器材資訊網

OnMarch16,2018-Medtronicannouncedavoluntaryrecallaffecting752CardiacResynchronizationTherapyDefibrillators(CRT-Ds)andImplantable ...

Publication Date: March 19, 2018

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[1] 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...