FDAMarch 17, 2023device
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
What to do
FDA enforcement status: Ongoing
Brands named
medtronic neuromodulationmedtronic
UPCs
00763000486518
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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