INFINION CX LEAD KIT — Class I medical device recall Z-2879-2026
Ongoing recall by Boston Scientific Neuromodulation Corporation, reported 2026-08-12, distributed in NY. Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may result in high
| Recall number | Z-2879-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Neuromodulation Corporation, Valencia, CA, United States |
| Recall initiated | 2026-06-17 |
| Classified | 2026-08-05 |
| Reported by FDA | 2026-08-12 |
| Distributed | NY |
| Countries outside the US | AE, AR, BR, CA, CO, CZ, DE, ES, FR, GB, GR, HU, IE, IL, IT, NL, PT, RS |
| Quantity | 1,079 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 08714729861614, 08714729861638 |
| Model numbers | SC-2317-50, SC-2317-70 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2879-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.