AxiEM" Non-Invasive Patient Tracker
FDA device recall Z-1039-2023 · posted 2023-01-30 · Open, Classified
Recall details
- Recalling firm
- Medtronic Navigation, Inc.
- 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.
- Action taken
- 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 neuro.quality@medtronic.com. 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 rs.navtechsupport@medtronic.com.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- HAW
- Quantity affected
- 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,
- Date initiated
- 2022-12-15
- Date posted
- 2023-01-30
- Location
- Louisville, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STYLET, 23CM, SKULL-MOUNT PATIENT TRACKER, NON-INVASIVE PATIENT TRACKER, TRACER POINTER, TOUCH-N-GO POINTER, NAVIGATION (K141833) | Medtronic Navigation, Inc. | 2015-03-25 |