Non-Invasive Patient Tracker Verification Failure During Image-Guided Surgery
Medtronic is recalling AxiEM Non-Invasive Patient Trackers due to increasing complaints that users cannot verify their navigation instruments work properly during image-guided surgery. The verification failure affects approximately 1,867 devices worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Class II medical device recall with no reported illnesses or injuries. The hazard is a risk-of-harm scenario where a surgical navigation device cannot be properly verified during use, potentially allowing undetected malfunction. This meets the rubric criterion for High severity: risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medtronic Navigation, Inc. is recalling the AxiEM Non-Invasive Patient Tracker system due to an increasing complaint trend where users are unable to successfully verify that their navigation instruments are functioning properly during image-guided surgical procedures.
The recall affects approximately 1,867 devices distributed worldwide, including to U.S. states: Alabama, Arkansas, Arizona, California, Colorado, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. Distribution also extended to Japan.
Affected users should contact Medtronic Navigation, Inc. regarding this verification issue.
The recalled product
- Product
- AxiEM" Non-Invasive Patient Tracker
- Manufacturer
- Medtronic Navigation, Inc.
- Affected units
- 1,867
Distribution
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