Medtronic Navigation, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1039-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

AxiEM" Non-Invasive Patient Tracker

Product Classification:

Class II

Date Initiated: December 15, 2022

Date Posted: February 8, 2023

Recall Number: Z-1039-2023

Event ID: 91354

Reason for 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.

Status: Ongoing

Product Quantity: 1,867 devies

Code Information:

Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00763000588380 Lot Number: 220728I 220729 Product Number/CFN: 9734887XOM UDI-Device Identifier (GTIN/UPN): 00643169608252 Lot Number: 220728I

Distribution Pattern:

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 Japan.

Voluntary or Mandated:

Voluntary: Firm initiated