Recall Z-2645-2016— Medtronic Neuromodulation

Class II FDA medical device recall by Medtronic Neuromodulation, initiated 2016-06-23, terminated 2017-09-21. FDA's recall record names no specific 510(k) clearance for this event. Product: DBS Pocket Adaptor, Model 64001 and Model 64002. The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.. Reason: Due to the potential for pocket adaptor conductor wire fractures involving DBS Pocket Adaptor Model 64001 and Model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures..

Recalling firm

Medtronic Neuromodulation

Classification

Class II

Status

Terminated

Initiated

2016-06-23

Terminated

2017-09-21

Firm location

Minneapolis, MN, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.