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Relay®pro thoracic stent-graft system
Official notice
29 May 2026
An official Health Canada notice concerns Relay®pro thoracic stent-graft system. Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke. Published 2026-05-29.
What to do now
Contact the manufacturer if you require additional information.
Recall number
82141
Official notice
2026-05-29
The hazard
The hazard
Through post-market surveillance, Bolton Medical received complaints where the graft is unable to unclasp from the delivery system because the proximal clasp is disconnected from the outer control tube. This may be recognized by the user as a lack of resistance felt when sliding the apex holder back accompanied by a failure to release the proximal stent. The implant cannot be recaptured at this stage in the procedure. Bolton Medical received 4 complaints associated with this failure mode, 3 of which resulted in death including 1 aortic perforation, and 2 conversions to open surgery which resulted in patient deaths due to stroke.
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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Risk / hazard
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.
Location 1
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Company & contacts
Company & contacts
Brand: Bolton Medical.
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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