Nalu Medical, Inc. 71007Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812537037356), received between Jan 14, 2025 and Feb 19, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 19, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT FOOT PAIN. AT THE TIME OF THE INITIAL SYSTEM ACTIVATION THE PATIENT REPORTED GOOD HEALING AND RECEIVING 100% PAIN RELIEF FROM THE SYSTEM. ON (B)(6) 2025 THE PATIENT NOTICED SOME REDNESS AND DISCOMFORT AT THE INCISION SITE FOR THE IMPLANTABLE PULSE GENERATOR (IPG). PATIENT WAS EVALUATED BY THE PRIMARY DOCTOR (NOT THE IMPLANTING DOCTOR) AND INFORMED AN INFECTION MAY BE DEVELOPING. THE PRIMARY DOCTOR CLEANED THE SITE AND PRESCRIBED ORAL ANTIBIOTICS. AFTER BEING SEEN BY THE PRIMARY DOCTOR, THE PATIENT THEN NOTIFIED THE IMPLANTING DOCTOR OF THE POSSIBLE INFECTION. THE IMPLANTING DOCTOR ADVISED TO REMOVE THE SYSTEM AND CULTURE TO DETERMINE INFECTION TYPE. ON (B)(6) 2025 THE IPG WAS REMOVED, HOWEVER THE DOCTOR WAS UNCOMFORTABLE REMOVING THE LEADS AS THEY WERE SCARRED IN CLOSE PROXIMITY TO THE TIBIAL NERVE.

  Patient problems: Post Operative Wound Infection

  MAUDE report 24393123 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS IMPLANTED WITH TWO NALU PNS SYSTEMS ON (B)(6) 2025 TO TREAT BILATERAL LOWER EXTREMITY PAIN. EACH SYSTEM WAS IMPLANTED SUCH THAN AN IMPLANTABLE PULSE GENERATOR (IPG) WAS IN THE LATERAL THIGH AREA AND IMPLANTED LEADS TARGETED THE SCIATIC NERVE. ON (B)(6) 2025 A NALU REPRESENTATIVE WAS NOTIFIED THAT THE PATIENT HAD DEVELOPED AN INFECTION IN THE RIGHT LOWER EXTREMITY AT THE SURGICAL INCISION SITE. A FULL SYSTEM EXPLANT TOOK PLACE ON (B)(6) 2025.

  Patient problems: Post Operative Wound Infection

  MAUDE report 22683273 ↗
• InjuryJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2024 TO TREAT RIGHT LOWER EXTREMITY PAIN. WHEN A NALU REPRESENTATIVE ATTEMPTED TO ACTIVATE THE SYSTEM DURING A POST-OP VISIT, THE PATIENT REPORTED NO SENSATION FROM THE DEVICE AND TESTING RETURNED LOW IMPEDANCE READINGS. DURING THE ACTIVATION, THE PHYSICIAN NOTED SOME PAIN AND SLIGHT REDNESS AT THE INCISION SITE AND SUSPECTED INFECTION. PHYSICIAN RECOMMENDED TO EXPLANT THE SYSTEM DUE TO THE SUSPECTED INFECTION. ON (B)(6) 2024 THE SYSTEM WAS EXPLANTED AND THE PHYSICIAN REPORTED NO SIGNS OF INFECTION UPON OPENING THE SITE. DURING THE EXPLANT PROCEDURE IT WAS DISCOVERED THAT THE IMPLANTED LEAD HAD BECOME DISCONNECTED FROM THE IMPLANTABLE PULSE GENERATOR (IPG) AND THAT HAD BEEN THE CAUSE OF THE PATIENT'S DISCOMFORT AT THE INCISION SITE.

  Patient problems: Discomfort

  MAUDE report 21147626 ↗