CanadaInterStim Systems percutaneous extensions (models 3560030, 3560022) and InterStim SureScan MRI Lead Kits (models 978B133, 978B141, 978A128, 978A133, 978B128) are affected; affected units can be identified by those model/catalog numbers and lot or serial numbers consisting of more than 10 numbers—contact the manufacturer for specific serials. Medtronic received 15 complaints that an incompatible component was selected for the intended system configuration, causing delayed surgery or the need for surgical replacement, and advises contacting the manufacturer for additional information.
What's being recalled
Companies: Medtronic Inc., 710 Medtronic Parkway N.E., Minneapolis, Minnesota, United States, 55432.
How to identify it
Affected products: InterStim™ Percutaneous Extension; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3560030
Affected products: InterStim™ Percutaneous Extension; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 3560022
Affected products: InterStim™ SureScan™ MRI Lead Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 978B133
Affected products: InterStim™ SureScan™ MRI Lead Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 978B141
Affected products: InterStim™ SureScan™ MRI Lead Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 978A128
Affected products: InterStim™ SureScan™ MRI Lead Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 978A133
Affected products: InterStim™ SureScan™ MRI Lead Kit; Lot or serial number: More than 10 numbers, contact manufacturer.; Model or catalogue number: 978B128
The hazard
Medtronic has received 15 complaints involving the selection of an incompatible component based on the intended system configuration between 01-Jan-2020 through 12-Aug-2026. Use of an incompatible lead or percutaneous extension has resulted in a delay of surgery or the need for surgical replacement of the component. Review of complaint data confirmed that the product is functioning as designed and there are no device or product performance issues.
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)