Use caution Medical device recall · FDA · Published September 26, 2018

Medtronic StealthStation Cranial Depth Gauge: Incorrect biopsy depth display risks healthy

Medtronic recalls StealthStation Cranial and Synergy Cranial Depth Gauges with software versions 2.2.0-3.1.0 that may cause biopsy of healthy tissue due to incorrect depth display.

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

🇺🇸 FDA recall #Z-0552-2019Medical device Medtronic ›

Use caution until it’s fixed

An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software, which resulted in the biopsy of healthy tissue.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Medtronic is recalling StealthStation Cranial and Synergy Cranial Depth Gauges that have a software bug causing the device to show incorrect biopsy depth. This could lead to surgeons accidentally removing healthy tissue during procedures. Affected units include specific software versions and related kits. Read more at govinfonow.com/recall/69762-medtronic-stealthstation-cranial-depth-gauge-incorrect-biopsy-depth-display-risks.

Source Summary by GovInfoNow · govinfonow.com/recall/69762-medtronic-stealthstation-cranial-depth-gauge-incorrect-biopsy-depth-display-risks · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0552-2019

Cite this page

“Medtronic StealthStation Cranial Depth Gauge: Incorrect biopsy depth display risks healthy.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/69762-medtronic-stealthstation-cranial-depth-gauge-incorrect-biopsy-depth-display-risks. Based on FDA recall #Z-0552-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0552-2019%22&limit=1).

The FDA announced on Sept. 26, 2018, that Medtronic is recalling StealthStation Cranial and Synergy Cranial Depth Gauge devices due to an incorrect display of the Biopsy Depth Gauge graphical representation. This hazard resulted in the biopsy of healthy tissue. The agency classified the recall as Class I.

How to tell if you have it

Brand: Medtronic
Product: StealthStation Cranial and Synergy Cranial Depth Gauge
Affected Software Versions: StealthStation Cranial version 3.0, 3.1; Synergy Cranial versions 3.0.0, 3.0.1, 3.0.2, 3.1.0; StealthStation S7 Cranial software kit CFN 9733763 versions 2.2.0, 2.2.5, 2.2.6, 2.2.7
Units affected: 5487 impacted systems

The hazard

An incorrect display of the Biopsy Depth Gauge graphical representation in the Guidance View using Cranial software resulted in the biopsy of healthy tissue, according to the FDA. The recall is classified as Class I.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has had 25 other recalls on record since June 7, 2017. Recent Medtronic recalls include a Dec. 4, 2024, recall of PIN surgical pins that may not fit patient reference frames and an Aug. 22, 2024, recall of StealthStation S8 App versions 1.3.0 and 1.3.2 for software issues causing flipped images. Other recent recalls of similar products include Howmedica Stryker CranialMask Tracker (Nov. 12, 2025), Bard Breast Biopsy System (Aug. 20, 2026), and Alphatec LIF NAV Osteotome 10mm (Jan. 2, 2026).

How to tell if you have this one

Check if your device has software versions 2.2.0-2.2.7 (Synergy Cranial) or 3.0.0-3.1.0 (StealthStation S7 Cranial). The affected units include specific kits and software packages listed in the recall notice.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Software Version
Verify your software version by checking the device's settings or documentation. Affected versions are 2.2.0-2.2.7 for Synergy Cranial and 3.0.0-3.1.0 for StealthStation S7 Cranial.
Update Software
Download and install the latest software update from Medtronic to fix the depth display issue. Updates are available for affected versions.

Where it went and when

Where it was distributed

Distributed in 48 states and D.C. and Puerto Rico, and outside the U.S.

FDA distribution: “US: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, Guam, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY OUS: Albania,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA terminated this recall 5.9 years after the firm started it.

Sep 26, 2018Firm started the recall
Dec 29, 2018FDA classified it Class I
Jan 9, 2019Published in FDA’s Enforcement Report
Sep 5, 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/69762-medtronic-stealthstation-cranial-depth-gauge-incorrect-biopsy-depth-display-risks">Medtronic StealthStation Cranial Depth Gauge: Incorrect biopsy depth display risks healthy (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-0552-2019 (September 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0552-2019 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.