SenSight recallZ-0121-2024 · Medtronic Neuromodulation · initiated Jan 20, 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 is requesting return of a small number of units of the SenSight Connector Plug, Model B31061, due to a discrepancy in the Use By Date (UBD) printed on the label.
FDA root cause category: Labeling Change Control
What the company is doing
Medtronic issued a MEDICAL DEVICE REMOVAL notice to its consignees on 01/20/2023 by mail. Consignees were asked to return any affected product they may have, and to forward this notification to those who need to be aware within the organization or to any location which the devices have been transferred.
Recall details
- Recall number
- Z-0121-2024
- Status
- Open, Classified
- Initiated by the company
- Jan 20, 2023
- Posted by the FDA
- Oct 18, 2023
- Recalling firm
- Medtronic Neuromodulation
- Quantity
- 65 devices
- Product code
- MHY
- FDA submissions
- P960009S391
- Distribution
- US Nationwide Distribution
Product description
SenSight Connector Plug, Model Number B31061.
Code information (models, lots, serial numbers)
GTIN 00763000426576, Lot Number 082U30721
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- SenSight™ B31061Medtronic, Inc. · implanted subcortical electrical Stimulator (motor disorders)1 recall20 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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