Health Canada Recalls Medtronic Deep Brain Stimulation Leads
Medtronic’s deep brain stimulation lead kits are being recalled by Health Canada under a Class I recall.
According to Medtronic, the threaded area of the depth stop accessory doesn’t extend close enough to the handle, preventing it from securing firmly to the DBS lead during implantation.
The problem could result in the lead being implanted beyond the intended target, which could have serious consequences for patients.
The recall affects the depth stop accessory provided in all Medtronic DBS lead kits.