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Stealth autoguide™ tracker
Official notice
7 Dec 2021
Last checked
7 Dec 2021
An official Health Canada notice concerns Stealth autoguide™ tracker. 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 Published 2021-12-07.
What to do now
Contact the manufacturer if you require additional information.
Recall number
63689
Official notice
2021-12-07
The hazard
The hazard
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
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
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Company & contacts
Company & contacts
Brand: Medtronic Navigation, Stealth Autoguide™ Tracker.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
See the official notice and source documents for full details.
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