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

FDA device recall Z-1617-2015 · posted 2015-05-15 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

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).

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.

Root cause

Under Investigation by firm

Status

Terminated

Product code

MHY

Quantity affected

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

Distribution

worldwide

Date initiated

2015-04-16

Date posted

2015-05-15

Date terminated

2016-07-22

Location

Minneapolis, MN