Recall MonitorHealth Products
InterStim™ Systems
· Published by Health Canada · Official notice
Details
Alert type: Health product recall
Category: Health products - Medical devices - Gastroenterology and urology
Product: InterStim™ Systems
Issue: Medical devices - Device compatibility
What to do: Contact the manufacturer if you require additional information.
Audience: Healthcare
Recall class: Type II
Products
| Affected products | Lot or serial number | Model or catalogue number |
|---|---|---|
| InterStim™ Percutaneous Extension | More than 10 numbers, contact manufacturer. | 3560030 |
| InterStim™ Percutaneous Extension | More than 10 numbers, contact manufacturer. | 3560022 |
| InterStim™ SureScan™ MRI Lead Kit | More than 10 numbers, contact manufacturer. | 978B133 |
| InterStim™ SureScan™ MRI Lead Kit | More than 10 numbers, contact manufacturer. | 978B141 |
| InterStim™ SureScan™ MRI Lead Kit | More than 10 numbers, contact manufacturer. | 978A128 |
| InterStim™ SureScan™ MRI Lead Kit | More than 10 numbers, contact manufacturer. | 978A133 |
| InterStim™ SureScan™ MRI Lead Kit | More than 10 numbers, contact manufacturer. | 978B128 |
Issue
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.