CanadaThe Axonics SNM System® Tined Lead (model 1201) is affected; look for the Axonics SNM System Tined Lead with catalogue number 1201. It was recalled because in a small percentage of cases the lead may be difficult to advance through the introducer sheath during implantation due to excess adhesive on the tines, affecting sheath compatibility, while implanted device performance is not affected. Contact the manufacturer for additional information.
What's being recalled
Companies: Axonics, Inc., 15515 Sand Canyon Ave., Irvine, California, United States, 92618.
How to identify it
Affected products: Axonics SNM System® - Tined Lead; Lot or serial number: Not applicable.; Model or catalogue number: 1201
Affected products: Tined Lead; Lot or serial number: Not applicable.; Model or catalogue number: 1201
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.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)
United States