Health product recall

Stealth Autoguide™ Tracker

Last updated

Summary

Product
Stealth Autoguide™ Tracker
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products

Lot or serial number

Model or catalog number

Stealth Autoguide™ Tracker

All lots.

28248

Issue

Medtronic has identified, through internal testing, that the weld where the tracker connects to the instrument tube may be subject to separation failure. While separation of the stealth autoguide tracker at the welded joint has not been reported by customers, Medtronic's testing identified the potential for this to occur and render the device unusable. If the weld separation is not identified prior to use, the issue has the potential to cause navigational inaccuracy. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury, including the potential for a life-threatening injury (hemorrhage, unintended tissue damage, permanent neurological injury) which could lead to death.

Recall start date: Nov 12, 2021

Additional information

Details
Original published date: 2021-12-10
Alert / recall type
Health product recall
Category
Health product - Medical device - General and plastic surgery
Companies
Medtronic Navigation, Inc.

826 Coal Creek Circle, Louisville, Colorado

United States, 80027

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63689