Use caution Medical device recall · FDA · Published November 9, 2021

Medtronic Stealth Autoguide Tracker 28248 Recall: Risk of Tissue Injury During Surgery

Medtronic recalls Stealth Autoguide Tracker model 28248 due to potential separation causing tissue injury during neurosurgery. Affected units include those in the Stealth Autoguide Basic Instrument Kit.

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

🇺🇸 FDA recall #Z-0417-2022Medical device Medtronic ›

Use caution until it’s fixed

A tracker that holds and guides neurosurgical surgical instruments may be subject to separation/weld failure, where the tracker connects to the instrument tube. If a weld separation occurs and a navigation inaccuracy is experienced, it may result in prolonged procedure and tissue injury. Per 11/24/21 firm email: The Bundle Autoguide Reg Kit does not have a model number. The Bundle Autoguide Reg Kit is internal terminology and not visible to the customer and are used as sales and shipping configuration only. When this sales bundle is chosen by an internal Medtronic Sales Representative the devices included in the bundle are individually packaged and labeled and sent to the customer in a single shipment. The devices included in the bundle are ordered, packed, and shipped as individual medical devices with unique model numbers, which is the reason that the Autoguide Tracker (28248) and the Stealth Autoguide Basic Instrument Kit (9736188) are the only part numbers subject to this FCA.

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 Stealth Autoguide Tracker model 28248 because it may separate during surgery, leading to tissue injury. This recall affects instruments used in neurosurgical procedures. Read more at govinfonow.com/recall/61556-medtronic-stealth-autoguide-tracker-28248-recall-risk-of-tissue-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/61556-medtronic-stealth-autoguide-tracker-28248-recall-risk-of-tissue-injury · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0417-2022

Cite this page

“Medtronic Stealth Autoguide Tracker 28248 Recall: Risk of Tissue Injury During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61556-medtronic-stealth-autoguide-tracker-28248-recall-risk-of-tissue-injury. Based on FDA recall #Z-0417-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0417-2022%22&limit=1).

The FDA announced on 2021-11-09 that Medtronic Navigation, Inc. is recalling Stealth Autoguide Trackers due to potential weld separation. This defect may cause navigation inaccuracy and tissue injury during neurosurgery.

How to tell if you have it

Brand: Medtronic
Product: Stealth Autoguide Tracker, Model: 28248
Part of Stealth Autoguide Basic Instrument Kit, Model: 9736188
All lot numbers

The hazard

A tracker that holds and guides neurosurgical instruments may suffer weld failure where it connects to the instrument tube. If separation occurs, navigation inaccuracy may result in prolonged procedure and tissue injury.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since 2017-06-07. Recent issues include 2024-12-04 surgical pins that may not fit patient reference frames and 2024-08-22 StealthStation S8 App software anomalies causing flipped images. Other recent recalls of similar products include Medtronic Bio-Medicus Adult Cannula Kit Recall (2026-05-25), Boston Scientific ENROUTE Transcarotid Neuroprotection System Recall (2026-07-09), and Alphatec LIF NAV Osteotome 10mm (2026-01-02).

How to tell if you have this one

Check for the model number 28248 on the Stealth Autoguide Tracker. The product is part of the Stealth Autoguide Basic Instrument Kit (9736188) sold as a bundle with unique model numbers.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Model
Look for the model number 28248 on the Stealth Autoguide Tracker.
Contact Medtronic
Reach out to Medtronic for specific guidance on handling the recalled item.

Where it went and when

Where it was distributed

Distributed in 21 states, and outside the U.S.

FDA distribution: “US: FL, NE, CA, MN, TX, OH, IL, AZ, KS, KY, OR, OK, WA, NV, MO, IN, MI, UT, MS, VA, SC. OUS: Canada, Sweden, Italy, France, Germany, Spain, Czech Republic, United Kingdom, India, Nepal, Japan, Turkey, China” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Florida, Illinois, Indiana, Kansas, Kentucky, Michigan, Minnesota, Mississippi, Missouri, Nebraska, Nevada, Ohio, Oklahoma, Oregon, South Carolina, Texas, Utah, Virginia, Washington.

Recall timeline

FDA published this recall 50 days after the firm started it.

Nov 9, 2021Firm started the recall
Dec 22, 2021FDA classified it Class II
Dec 29, 2021Published in FDA’s Enforcement Report

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

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to stop using the tracker immediately?

The recall requires checking the model number and contacting Medtronic for specific guidance, not immediate discontinuation.

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Link to this recall

<a href="https://govinfonow.com/recall/61556-medtronic-stealth-autoguide-tracker-28248-recall-risk-of-tissue-injury">Medtronic Stealth Autoguide Tracker 28248 Recall: Risk of Tissue Injury During Surgery (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-0417-2022 (November 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0417-2022 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.