Medtronic Nexframe Stereotactic System and StealthStation Cranial… — Class I medical device recall Z-1995-2020
Terminated recall by Medtronic Navigation, Inc., reported 2020-05-27, distributed nationwide. Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occ
| Recall number | Z-1995-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medtronic Navigation, Inc., Louisville, CO, United States |
| Recall initiated | 2019-08-09 |
| Classified | 2020-05-18 |
| Reported by FDA | 2020-05-27 |
| Terminated | 2024-04-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, CA, ES, GB, IT, RO |
| Quantity | 61 customers |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00613994747877, 00643169214811, 00643169625549, 00643169878204, 00643169986763, 00643169986770, 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055 and 23 more |
Product
Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License and O-arm Imaging System utilizing the auto-registration (fiducial- less) workflow used in combination during a DBS (deep brain stimulation) procedure. Neurological stereotaxic Instrument.
Reason for recall
Entry point and lead placement inaccuracies during deep brain stimulation lead implantation procedures may occur when using a specific combination of the firm's Steriotactic System and auto-registration feature with a specific imaging system (also known as a fiducial-less procedure). Minor patient movement may not be initially detected by the user or the software during the auto-registration scan process potentially resulting in inaccuracies and risks for the patient including: inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention (including revision of the lead placement and subsequent imaging).
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-1995-2020. 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.