Nalu Medical, Inc. 72011Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00812537037226), received between Jan 10, 2025 and Jul 27, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Migration” (2 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 27, 2026Migration

  The patient was implanted with a Nalu Peripheral Nerve Stimulator (PNS) system in (b)(6)2025 and after several months of use the patient reported loss of therapy. Imaging was performed and found that the leads that had been placed to target the medial branch nerve had migrated away from the intended target location, causing the loss of therapy. Any surgical intervention to reposition or replace the leads was delayed due to the patient's cardiac health and lack of medical clearance for moving forward with the procedure. In July 2026 the patient was cleared for surgery and on (b)(6)2026 the original, non-tined system was removed and a new system utilizing tined style leads was placed, targeting the medial branch and medial cluneal nerves

  Patient problems: Inadequate Pain Relief

  MAUDE report 50024258 ↗
• InjuryJan 20, 2026Migration

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR ON (B)(6) 2025 TO TREAT BACK PAIN. APPROXIMATELY 3 MONTHS AFTER THE INITIAL IMPLANT, THE PATIENT REPORTED A LOSS OF STIMULATION. EVALUATION OF THE SYSTEM FOUND THAT THE IMPLANTED LEAD HAD MIGRATED AWAY FROM THE INTENDED NERVE TARGET, CAUSING LOSS OF THERAPY AT THE SITE OF PAIN. MULTIPLE REPROGRAMMING SESSIONS WERE CONDUCTED TO ATTEMPT TO IMPROVE THERAPY BUT WERE UNSUCCESSFUL. A SURGICAL REVISION WAS PERFORMED ON (B)(6) 2025 TO REMOVE THE MIGRATED LEADS AND PLACE NEW LEADS BACK AT THE INTENDED LOCATION.

  Patient problems: Inadequate Pain Relief

  MAUDE report 24114354 ↗
• InjuryMar 24, 2025Expulsion; Expulsion

  THE PATIENT WAS IMPLANTED WITH A NALU NERVE STIMULATOR SYSTEM ON (B)(6)2024 TO TREAT UPPER BACK PAIN. ON (B)(6) 2025 THE PATIENT NOTED THAT THE LEAD IMPLANTED IN THE THORASIC PARASPINAL TISSUE APPEARED TO BE ERODING THROUGH THE SKIN. THE PHYSICIAN WAS NOTIFIED AND THE PATIENT WAS SEEN ON (B)(6) 2025 FOR EVALUATION. UPON EXAMINATION, THE PHYSICIAN DETERMINED THAT THE ANCHOR HOLDING THE LEAD IN PLACE WAS MIGRATING UP AND THROUGH THE SKIN. NO REDNESS, SWELLING, OR DISCHARGE WAS NOTED AT ANY OF THE SURGICAL SITES OR THE LOCATION OF THE EXPOSED IMPLANT. ALL LAB CULTURES WERE REPORTED AS NORMAL AND THE PATIENT STATED NO FEVER OR CHILLS. ON (B)(6) 2025 THE PHYSICIAN REMOVED THE EXPOSED LEAD, IRRIGATED THE SITE WITH ANTIBIOTICS, AND CLOSED THE SITE, LEAVING THE IMPLANTABLE PULSE GENERATOR (IPG) AND THE SECOND IMPLANTED LEAD IN PLACE. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS FOR HOME USE AS A PRECAUTION.

  Patient problems: Skin Erosion

  MAUDE report 21684448 ↗
• InjuryJan 10, 2025Migration or Expulsion of Device; Migration or Expulsion of Device

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024. DURING A POST-OPERATION WOUND CHECK ON (B)(6) 2024 THE PATIENT WAS FOUND TO HAVE THE DISTAL END OF THE IMPLANTED LEAD PROTRUDING THROUGH THE SKIN AT A SURGICAL NEEDLE PUNCTURE SITE. THE EXPOSED LEAD WAS SURGICALLY EXPLANTED ON (B)(6) 2024. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS LEFT IMPLANTED IN ANTICIPATION OF PLACING A NEW LEAD AT A LATER DATE.

  Patient problems: Wound Dehiscence

  MAUDE report 21121597 ↗