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Health product recall

Specify Lead Kits (2016-01-06)

Starting date:
January 6, 2016
Posting date:
February 1, 2016
Type of communication:
Medical Device Recall
Subcategory:
Medical Device
Hazard classification:
Type III
Source of recall:
Health Canada
Issue:
Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-56898

Affected Products

  1. SPECIFY 5-6-5 LEAD KIT
  2. SPECIFY 2X8 LEAD KIT

Reason

The purpose is to notify that labeling is being updated to clarify that the Specify 5-6-5 and 2x8 surgical leads are not intended for interoperative trial evaluation use (i.e., trialing/screening outside of the operating room with an external neurostimulator). Some Specify 5-6-5 and 2x8 surgical lead product labeling does not distinguish between intraoperative stimulation testing with a permanent surgical lead and interoperative trial evaluation use.

Affected products

  1. SPECIFY 5-6-5 LEAD KIT

Lot or serial number

All Lots

Model or catalog number
  • 39565
Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

B. SPECIFY 2X8 LEAD KIT

Lot or serial number

All Lots

Model or catalog number

39286

Companies
Manufacturer
Medtronic Inc.
710 Medtronic Parkway NE
Minneapolis
55432
Minnesota
UNITED STATES

Date modified: