FDA Device recall Z-2879-2026
INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500
- FDA Device
- Class I
- ongoing
- Published 2026-08-12
On 2026-08-12 the FDA classified a Class I recall of INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500 by Boston Scientific Neuromodulation, citing 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 inadequat….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2879-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-06-17 |
| Published | 2026-08-12 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific Neuromodulation |
| Distribution | NY |
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.
Identifiers
| code_info | Model/UDI-DI: SC-2317-50/08714729861614, SC-2317-70/08714729861638. All unused products. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2879-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.