Z-1617-2015Class II

Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile

Name: Z-1617-2015 Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Creator: Medtronic Neuromodulation
Published: 2015-04-16
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2015-04-16 / Terminated

FDA source

Medtronic Neuromodulation began a recall of Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile on 2015-04-16. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1617-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-16
Posted: 2015-05-15
Terminated: 2016-07-22
Recalling firm: Medtronic Neuromodulation
Product: Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
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).
FDA 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 [email protected]. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.
Quantity in commerce: 86,851 (US 37,933 / OUS 48,918)
Distribution: worldwide
Product codes and lots: all Serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1617-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1617-2015	Class II	Terminated	Voluntary: Firm initiated	2015-05-27	2015-05-15

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)