Recall Z-1039-2023— Medtronic Navigation, Inc.

Name: FDA recall Z-1039-2023
Creator: U.S. Food and Drug Administration
Published: 2022-12-15

Class II · Ongoing

Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2022-12-15. It names one FDA 510(k) clearance: K141833. Product: AxiEM" Non-Invasive Patient Tracker. Reason: 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..

Recalling firm: Medtronic Navigation, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-12-15
Firm location: Louisville, CO, United States

510(k) clearances named in this recall

1 on FDA's record

K141833 — STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATIONMedtronic Navigation, Inc.·cleared 2015-03-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AxiEM" Non-Invasive Patient Tracker

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.