Medtronic recalls AxiEM Non-Invasive Patient Tracker devices due to issues verifying navigation instruments during image-guided surgery. Affected units have specific product numbers and lot dates.
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.
Medtronic is recalling AxiEM Non-Invasive Patient Tracker devices because users report failing to verify navigation instruments during image-guided surgery. This could lead to incorrect surgical guidance if the system doesn't work properly.
The system may not correctly verify navigation instruments during surgery, which could lead to incorrect surgical guidance if the device fails to function as intended. This is a reporting issue rather than a physical defect causing immediate harm.
Surgical teams using the AxiEM Non-Invasive Patient Tracker for image-guided procedures. Patients and staff at medical facilities that purchased the recalled units are most at risk.
Check for product numbers 9734887XOM and lot numbers 220728I or 220729. The device was sold with specific UDI identifiers and lot dates.
Review the product number and lot number on your AxiEM device to confirm if it matches the recalled units.
The recall is due to reported issues verifying navigation instruments during surgery, but the device itself is not considered dangerous in normal use.
Check for product number 9734887XOM and lot numbers 220728I or 220729 on your device.
The recall does not require immediate action; check your device details to see if it matches the affected units.
We’ve drafted a message you can send Medtr: AxiEM to request your refund or repair — edit it as you like.
Subject: Recall Z-1039-2023 — Medtr: AxiEM Medtr: AxiEM Hello, I own a Medtr: AxiEM that is covered by recall Z-1039-2023 from Medtr: AxiEM. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
