Z-2879-2026 Class I Ongoing
FDA device recall Z-2879-2026 was initiated by Boston Scientific Neuromodulation Corporation on Jun 17, 2026 and is designated Class I. Reason for recall: 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… The recall status is ongoing. Affected quantity: 1079.
Recall details
- Product Type
- Devices
- Report Date
- Aug 12, 2026
- Initiation Date
- Jun 17, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1079
Product description
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 for recall
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.
Distribution pattern
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
Code information
Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2879-2026
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026