SenSight recallZ-1408-2023 · Medtronic Neuromodulation · initiated Mar 17, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic Neuromodulation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
Medtronic issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 03/17/2023 via UPS 2-day delivery. The notice explained the issue and the hazard and requested the following actions be taken: Quarantine all unused product from the affected lots and return them as described on the Customer Confirmation Form. Pass the notice to all those who need to be aware within your organization or to any organization where the potentially affected product has been transferred or distributed.
Recall details
- Recall number
- Z-1408-2023
- Status
- Open, Classified
- Initiated by the company
- Mar 17, 2023
- Posted by the FDA
- Apr 19, 2023
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 1414 units
- Product code
- MHY
- FDA submissions
- P960009S391
- Distribution
- Worldwide distribution - US Nationwide and the countries of Austria, Belgium, Canary Islands, Czech Republic, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Luxembourg, Netherlands, New Zealand, Portugal, Slovakia, Spain, Sweden, Switzerland, United Kingdom.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SenSight™ B31030Medtronic, Inc. · INSTRUMENT, SURGICAL, NON-POWERED1 recall7 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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