FDA Medical Device Recalls (openFDA)
Medtronic Neuromodulation: Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Recall number
- Z-1617-2015
- Recalling firm
- Medtronic Neuromodulation
- Product
- Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
- Status
- Terminated
- Initiated
- 2015-04-16
- Posted
- 2015-05-15
- Terminated
- 2016-07-22
- Reason
- 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).
- Root cause
- Under Investigation by firm
- Action
- 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.
- Quantity
- 86,851 (US 37,933 / OUS 48,918)
- Distribution
- worldwide
- Lot, serial or model codes
- all Serial numbers
- 510(k) numbers
- not on file
- PMA numbers
- ["P960009"]
- Product code
- MHY
- Firm FEI
- 2182207
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28