Recall Z-1039-2023 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
AxiEM" Non-Invasive Patient Tracker
| Date | Jan 30, 2023 (initiated Dec 15, 2022) |
| Status | Open, Classified |
| 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. |
| 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 Conf |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141833 | STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION Medtronic Navigation, Inc., Mar 25, 2015 |