Lower risk Medical device recall · FDA · Published December 15, 2022

Medtronic AxiEM Non-Invasive Patient Tracker: Navigation Errors During Surgery

Medtronic recalls AxiEM Non-Invasive Patient Tracker devices due to issues verifying navigation instruments during image-guided surgery. Affected units have specific product numbers and lot dates.

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

🇺🇸 FDA recall #Z-1039-2023Medical device Medtr: AxiEM ›

Lower-risk recall

Due to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to successfully verify their navigation instruments during image-guided surgery.

Take action

Contact the company

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

✎ GovInfoNow plain-language explainer

Medtronic is recalling AxiEM Non-Invasive Patient Tracker devices because users report failing to verify navigation instruments during image-guided surgery. This could lead to incorrect surgical guidance if the system doesn't work properly. Read more at govinfonow.com/recall/59119-medtronic-axiem-non-invasive-patient-tracker-navigation-errors-during-surgery.

Source Summary by GovInfoNow · govinfonow.com/recall/59119-medtronic-axiem-non-invasive-patient-tracker-navigation-errors-during-surgery · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1039-2023

Cite this page

“Medtronic AxiEM Non-Invasive Patient Tracker: Navigation Errors During Surgery.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/59119-medtronic-axiem-non-invasive-patient-tracker-navigation-errors-during-surgery. Based on FDA recall #Z-1039-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1039-2023%22&limit=1).

The FDA announced on Dec. 15, 2022, that Medtronic Navigation, Inc. is recalling AxiEM Non-Invasive Patient Trackers due to a hazard where users cannot verify navigation instruments during surgery. The agency classified the recall as Class II.

How to tell if you have it

Brand: Medtronic AxiEM
Product Number/CFN: 9734887XOM
Lot Number: 220728I
UPC/GTIN: 00763000588380
Lot Number: 220729
UPC/GTIN: 00643169608252

The hazard

According to the FDA, complaints indicate that users are unable to successfully verify their navigation instruments during image-guided surgery. The recall involves 1,867 devices distributed worldwide and in U.S. states including Alabama, California, and New York.

Context

GovInfoNow's records show Medtronic Navigation, Inc. has 25 other recalls on record since June 7, 2017. Recent similar recalls include the Dec. 4, 2024, recall of Medtronic PIN surgical pins and the Aug. 22, 2024, recall of Medtronic StealthStation S8 App versions. Other recent recalls of similar products include the Howmedica Stryker CranialMask Tracker (Nov. 12, 2025), the GE Medical Systems Imactis CT-Navigation System (Feb. 3, 2026), and the Alphatec LIF NAV Osteotome 10mm (Jan. 2, 2026).

How to tell if you have this one

Check for product numbers 9734887XOM and lot numbers 220728I or 220729. The device was sold with specific UDI identifiers and lot dates.

Brand
Medtr: AxiEM
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Details
Review the product number and lot number on your AxiEM device to confirm if it matches the recalled units.

Where it went and when

Where it was distributed

Distributed in 40 states and D.C., and outside the U.S.

FDA distribution: “Worldwide - U.S. distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV. The country of…” States read from FDA’s own wording; “not listed” means the notice does not name it.

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

Recall timeline

FDA published this recall 55 days after the firm started it.

Dec 15, 2022Firm started the recall
Jan 30, 2023FDA classified it Class II
Feb 8, 2023Published in FDA’s Enforcement Report

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

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More Medtr: AxiEM recalls

Link to this recall

<a href="https://govinfonow.com/recall/59119-medtronic-axiem-non-invasive-patient-tracker-navigation-errors-during-surgery">Medtronic AxiEM Non-Invasive Patient Tracker: Navigation Errors 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-1039-2023 (December 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1039-2023 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.