Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AxiEM" Non-Invasive Patient Tracker Recalled by Medtronic Navigation, Inc. Due to Due to increasing complaint trend for the Non-Invasive...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Medtronic Navigation, Inc. directly.
Affected Products
AxiEM" Non-Invasive Patient Tracker
Quantity: 1,867 devies
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed to 41 states: AL, AZ, AR, CA, CO, DE, FL, GA, HI, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS, MO, MT, NE, NV, NJ, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WV, WI, DC
About Medtronic Navigation, Inc.
Medtronic Navigation, Inc. has 91 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report