Recall Monitor
Health Products

Axonics SNM System® - Tined Lead

· Published by Health Canada · Official notice

Details

Alert type: Health product recall
Category: Health products - Medical devices - Cardiovascular
Product: Axonics SNM System® - Tined Lead
Issue: Medical devices - Performance
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
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Products

Affected productsLot or serial numberModel or catalogue number
Axonics SNM System® - Tined LeadNot applicable.1201
Tined LeadNot applicable.1201

Issue

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.

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