FDA Device recall Z-1408-2023
Medtronic SenSight Extension Tunneler Kit, REF B31030
- FDA Device
- Class II
- ongoing
- Published 2023-04-26
On 2023-04-26 the FDA classified a Class II recall of Medtronic SenSight Extension Tunneler Kit, REF B31030 by Medtronic Neuromodulation, citing 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 use….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1408-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-03-17 |
| Published | 2023-04-26 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medtronic Neuromodulation |
| Distribution | US |
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
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.
Identifiers
| code_info | UDI/DI00763000426361, Serial Numbers: HG56BR6, HG56C4R, HG56CJAH01, HG56CLE, HG586N7, HG586UM, HG58704, HG58VM0, HG58V…UDI/DI00763000426361, 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, HG5A9GT, HG5A9VY, HG5A9VZ, HG5AQH0, HG5AQQE, HG5BQ5Y, HG5BQLR, HG5BQPJ, HG5BTW7, HG5BTZX, HG5BU5W, HG5BU77, HG5EPSB, HG5EQ0C, HG5EQ2A, HG5EQ69, HG5F31N, HG5F338, HG5F3AZ, HG5F3EH, HG5F3G6, HG5F3K5, HG5F3NF, HG5FP0Y, HG5FP3B, HG5FP70, HG5FP70H01, HG5FPBE, HG5HQBM, HG5HQF8, HG5LJTL, HG5LJZQ, HG5LK2J, HG5LK4H, HG5LK5Y, HG5LK7C, HG5LK8P, HG5LK92, HG5LKAL, HG5LKC9, HG5LKEL, HG5LKGT, HG5LR02, HG5LR33, HG5LTWA, HG5LTWP, HG5LTXU, HG5LTYY, HG5LU12; UDI/DI 00763000486518, Serial Numbers: HG59ABH, HG59RY0, HG59SJ4, HG59SNC, HG5A9H3, HG5A9NB, HG5A9VY, HG5BQ5Y, HG5BQAW, HG5BQLR. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1408-2023%22
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