Z-1039-2023Class II

AxiEM" Non-Invasive Patient Tracker

Name: Z-1039-2023 AxiEM" Non-Invasive Patient Tracker
Creator: Medtronic Navigation, Inc.
Published: 2022-12-15
License: https://open.fda.gov/license/

Medtronic Navigation, Inc / initiated 2022-12-15 / Open, Classified / root cause: manufacturing process

FDA source

Medtronic Navigation, Inc. began a recall of AxiEM" Non-Invasive Patient Tracker on 2022-12-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1039-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-15
Posted: 2023-01-30
Recalling firm: Medtronic Navigation, Inc
Product: AxiEM" Non-Invasive Patient Tracker
Product code: HAW Neurological Stereotaxic Instrument
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On 12/15/2022, the firm sent an "URGENT: MEDICAL DEVICE RECALL" Letter via mail courier informing customers is recalling two specific lots of AxiEM Non-Invasive Patient Trackers due to the potential for verification failure of navigation instruments during a Functional Endoscopic Sinus Surgery procedure. Customer are instructed: 1. Do NOT use any impacted product. Immediately locate and quarantine all unused impacted product(s). Refer to the affected lot numbers identified in Table 1 below. 2. Return the impacted product(s) to Medtronic following the instructions in the enclosed Customer Confirmation Form. Their Medtronic Sales Representative can assist in initiating the return of the product as necessary. 3. Complete the Customer Confirmation Form enclosed with this letter (even if they have no product to return), acknowledging that they have received this information, and email the completed form to Medtronic at [email protected]. 4. If the affected devices have already been utilized and/or discarded, the firm is still asking that customers complete and return the Customer Confirmation Form detailing that information. For questions, contact Medtronic Sales Representative or Medtronic Technical Services at 1-888-826-5603 or via email at [email protected].
Quantity in commerce: 1,867 devies
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 Japan.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1039-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1039-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-02-08	2023-01-30

Product code HAW

K141833Class IIStylet, 23Cm, Skull-Mount Patient Tracker, Non-Invasive Patient Tracker, Tracer Pointer, Touch-N-Go Pointer, NavigationMedtronic Navigation, Inc. / cleared 2015-03-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)