Medtronic SenSight Extension Tunneler Kit — Class II medical device recall Z-1408-2023
Ongoing recall by Medtronic Neuromodulation, reported 2023-04-26, distributed nationwide. Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been m
| Recall number | Z-1408-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Neuromodulation, Minneapolis, MN, United States |
| Recall initiated | 2023-03-17 |
| Classified | 2023-04-19 |
| Reported by FDA | 2023-04-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, BE, CH, CZ, DE, ES, FR, GB, GR, HU, IE, IL, IT, JP, LU, NL, NZ, PT, SE, SK |
| Quantity | 1,414 units |
| UPC / GTIN / UDI-DI | 00763000426361, 00763000486518 |
| Serial numbers | HG56BR6, HG56C4R, HG56CJAH01, HG56CLE, HG586N7, HG586UM, HG58704, HG58VM0, HG58VQH, HG58VQHH01, HG58VY5, HG58W7H, HG58WWC, HG58WYB, HG58WYBH01, HG58X0E, HG597BH, HG597DH, HG597M8, HG59ABH, HG59AFC, HG59AV6, HG59RY0, HG59SJ4, HG59SNC and 52 more |
| Model numbers | B31030 |
Product
Medtronic SenSight Extension Tunneler Kit, REF B31030; The Extension Tunneler Kit is used to assist in the tunneling and passage of extensions for deep brain stimulation
Reason for recall
Medtronic has received reports of SenSight Extension Tunneler kits that contain dual carriers with have been machined on only one side. As a result, the dual carrier cannot be used to pass two extensions simultaneously.
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-1408-2023. 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.