Use caution Medical device recall · FDA · Published August 9, 2019

Medtronic Nexframe System Software Version 3.0+ Risks Inaccurate Brain Surgery Leads

Medtronic recalls stereotactic surgery systems and software versions 3.0+ that may cause inaccurate brain implant lead placement during deep brain stimulation procedures. Affected units include specific models with O-arm imaging systems.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1995-2020Medical device Medtronic ›

Use caution until it’s fixed

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).

Take action

Contact the company

Recalling firmMedtronic Navigation, Inc.826 Coal Creek Cir · Louisville, CO 80027-9710

✎ GovInfoNow plain-language explainer

Medtronic is recalling its Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer that may cause inaccurate lead placement during deep brain stimulation surgery. This could lead to delayed or aborted procedures, additional surgery, or risks to the patient. Read more at govinfonow.com/recall/67240-medtronic-nexframe-system-software-version-3-0-risks-inaccurate-brain.

Source Summary by GovInfoNow · govinfonow.com/recall/67240-medtronic-nexframe-system-software-version-3-0-risks-inaccurate-brain · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1995-2020

Cite this page

“Medtronic Nexframe System Software Version 3.0+ Risks Inaccurate Brain Surgery Leads.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67240-medtronic-nexframe-system-software-version-3-0-risks-inaccurate-brain. Based on FDA recall #Z-1995-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1995-2020%22&limit=1).

The FDA announced on 2019-08-09 that Medtronic Navigation, Inc. is recalling the Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or newer with StealthStation DBS due to potential lead placement inaccuracies during deep brain stimulation procedures.

How to tell if you have it

Medtronic Nexframe Stereotactic System (GTINs: DB-2040, 00643169214811; MI-1000, 00643169986763; MI-2000, 00643169986770; NP-1000, 00613994747877)
StealthStation Cranial software version 3.0 or newer with StealthStation DBS License (GTINs: 00643169878204, 00643169625549) or StealthStation S8 Software with Stealth DBS License
O-arm Imaging System utilizing the auto-registration (fiducial-less) workflow (GTINs: 00763000068073, 00763000068080, 00763000068097, 00763000068103, 00763000074050, 00763000074067, 00763000074074, 00763000074081, 00763000074098, 00763000074104, 00763000074111, 00763000074128, 00763000074135, 00763000079000, 00763000079017, 00763000079024, 00763000079031, 00763000079048, 00763000079055, 00763000079062, 00763000079079, 00763000079086, 00763000079093, 00763000079109, 00763000079215, 00763000079246, 00763000079260, 00763000080969, 00763000080976, 00763000080983, 00763000080990, 00763000081003, 00763000081010, 00763000081027, 00763000081034, 00763000081041, 00763000081058, 00763000081065, 00763000081072, 00763000081089, 00763000081096 and 00763000081102)

The hazard

According to the FDA, entry point and lead placement inaccuracies may occur when using the specified combination of equipment with the auto-registration feature. Minor patient movement may not be detected during the scan, potentially resulting in inaccurate lead placement, delay of surgery, aborted surgery, or additional intervention.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Other recent recalls include Medtronic PIN surgical pins (2024-12-04), StealthStation S8 App versions 1.3.0 and 1.3.2 (2024-08-22), and Stealth S8 Software (2024-03-26). Other recent recalls of similar products include GE Medical Systems Imactis CT-Navigation System Recall (2026-02-03), Alphatec LIF NAV Osteotome 10mm (2026-01-02), and Hitachi Proton Beam Therapy System Recall (2026-02-06).

How to tell if you have this one

Check for Medtronic Nexframe Stereotactic System models with GTINs DB-2040, 00643169214811, MI-1000, 00643169986763, MI-2000, 00643169986770, or NP-1000, 00613994747877. Affected software versions include StealthStation Cranial 3.0+ with StealthStation DBS License or StealthStation S8 Software with Stealth DBS License used with O-arm Imaging Systems.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Affected Software
Immediately stop using the affected software versions during deep brain stimulation procedures until a fix is implemented.
Contact Medtronic
Reach out to Medtronic for guidance on alternative software versions or procedures to ensure safe surgery.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution including US nationwide, Austria, Canada, Italy, Romania, Spain, and United Kingdom.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide, and outside the U.S.

Recall timeline

FDA terminated this recall 4.6 years after the firm started it.

Aug 9, 2019Firm started the recall
May 18, 2020FDA classified it Class I
May 27, 2020Published in FDA’s Enforcement Report
Apr 2, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/67240-medtronic-nexframe-system-software-version-3-0-risks-inaccurate-brain">Medtronic Nexframe System Software Version 3.0+ Risks Inaccurate Brain Surgery Leads (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1995-2020 (August 9, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1995-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.