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Axonics snm system® - tined lead
Official notice
22 Oct 2025
Last checked
22 Oct 2025
An official Health Canada notice concerns Axonics snm system® - tined lead. Boston Scientific is writing to share information related to the tined lead component of the Axonics SNM System® Tined Lead Kit (model 1201). Boston Scientific has identified that in a small percentage of cases, users may experience difficulty advancing the tined lead through the introducer sheath during implantation, requiring device exchange during the procedure. Investigation determined that difficulty advancing the lead may be due to the amount of adhesive applied to the tine component during manufacturing, which may prevent them from fully deflecting within the sheath. Boston Scientific has since introduced controls to prevent this issue occurring in the future. This issue only affects sheath compatibility; the performance of implanted tined lead devices is not affected. Published 2025-10-22.
What to do now
Contact the manufacturer if you require additional information.
Recall number
78345
Official notice
2025-10-22
The hazard
The hazard
Boston Scientific is writing to share information related to the tined lead component of the Axonics SNM System® Tined Lead Kit (model 1201). Boston Scientific has identified that in a small percentage of cases, users may experience difficulty advancing the tined lead through the introducer sheath during implantation, requiring device exchange during the procedure. Investigation determined that difficulty advancing the lead may be due to the amount of adhesive applied to the tine component during manufacturing, which may prevent them from fully deflecting within the sheath. Boston Scientific has since introduced controls to prevent this issue occurring in the future. This issue only affects sheath compatibility; the performance of implanted tined lead devices is not affected.
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
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: Axonics, Axonics Snm System® - Tined Lead.
Source & status
Source & status
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Recall details
Recall details
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Documents, notices & source
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