Boston Scientific Neuromodulation Corporation: Stimulator, Spinal-cord, Totally Implanted For Pain Relief
Recall Summary Boston Scientific is recalling two sizes of INFINION CX spinal cord stimulator leads because the lead body may be exposed to stress at the anchor site, potentially causing lead fractures or high impedance measurements. This could result in the device stopping working properly and requiring additional surgery to remove and replace the lead. The recall affects patients in the US and multiple countries internationally who received these devices.
- Recalling firm
- Boston Scientific Neuromodulation Corporation
- Product
- INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INFINION CX LEAD KIT, 70CM, Model: SC-2317-70, Material: M365SC2317700. part of the Boston Scientific Spinal Cord Stimulator (SCS) Systems.
- Reason
- Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high impedance measurements or lead fractures, which may lead to inadequate stimulation, additional intervention, including lead explant and replacement.
- Classification
- Class III
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-06-17
- Status
- Open, Classified
- Areas affected
- NY
- Distribution
- US: NY. OUS: Canada, Portugal, Spain, France, Netherlands, Great Britain, Italy, Israel, Serbia, Greece, Germany, United Arab Emirates, Ireland, Hungary, Czech Republic, Brazil, Colombia, Argentina
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/cdea3148-cb12-46fe-96c9-ba80275ee549