Medtronic Neuromodulation: Medical Device Recall in 2015 - (Recall #: Z-1617-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 16, 2015

Date Posted: May 27, 2015

Recall Number: Z-1617-2015

Event ID: 71016

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).

Status: Terminated

Product Quantity: 86,851 (US 37,933 / OUS 48,918)

Code Information:

all Serial numbers

Distribution Pattern:

worldwide

Voluntary or Mandated:

Voluntary: Firm initiated