Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
This recall has been terminated (originally issued May 15, 2015).
- Company
- Medtronic Neuromodulation
- Recall Initiated
- April 16, 2015
- Posted
- May 15, 2015
- Terminated
- July 22, 2016
- Recall Number
- Z-1617-2015
- Quantity
- 86,851 (US 37,933 / OUS 48,918)
- Firm Location
- Minneapolis, MN
- Official Source
- View on FDA website ↗
Reason for Recall
Medtronic is providing Important information regarding extension handling during implant procedure after receiving reports of high impedances. This applies to extension Models 37085 and 37086 which can be used with the following implantable Neurostimulators: Activa PC (Model 37601), Activa RC (Model 37612), and the Activa SC (Model 37603).
Distribution
worldwide
Lot / Code Info
all Serial numbers
Root Cause
Under Investigation by firm
Action Taken
Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to neuro.quality@medtronic.com. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.