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Health product recall

Activa PC INS - DBS Extension Kit For Deep Brain Stimulation (2015-04-16)

Starting date:
April 16, 2015
Posting date:
May 21, 2015
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type II
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-53403

Recalled Products

A. Activa PC INS - DBS Extension Kit For Deep Brain Stimulation

Reason

Notification to communicate recent results from returned product analysis of Medtronic Neuromodulation Deep Brain Stimulation (DBS) system extensions with reports of high impedances, and reinforces device labeling specific to the handling of extensions and system integrity checking during implant procedures.

Affected products

A. Activa PC INS - DBS Extension Kit For Deep Brain Stimulation

Lot or serial number

All lots.

Model or catalog number
  • 37085
  • 37086
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
Minnesota
UNITED STATES