Nalu Medical, Inc. 34003Recalls & reported problems
Nalu Medical, Inc. · EIC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812537035055), received between Sep 6, 2025 and Sep 16, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Fracture” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
- Fracture1
Patient problems
- Inadequate Pain Relief1
- Unspecified Mental, Emotional or Behavioral Problem1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem
The Nalu Representative reported that the patient had been missing for several days of their Nalu trial and discovered that the patient was admitted to a care facility via the Baker Act. And the patient reportedly remains in a medical facility, possibly having also sustained a cardiac event. The Nalu trial leads were removed. There is no confirmation of a cardiac event, only patient assertion. Nalu trial leads were removed as designed.
Patient problems: Unspecified Mental, Emotional or Behavioral Problem
MAUDE report 50792854 ↗InjurySep 6, 2025Fracture; Fracture
PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6) 2025 TO TREAT KNEE PAIN. IN APPROXIMATELY (B)(6) 2025 THE PATIENT REPORTED LOSS OF STIMULATION FROM THE SYSTEM. XRAY IMAGING FOUND THAT BOTH IMPLANTED LEADS HAD FRACTURED. ON (B)(6) 2025 A FULL SYSTEM EXPLANT WAS PERFORMED DUE TO THE FRACTURED COMPONENTS.
Patient problems: Inadequate Pain Relief
MAUDE report 22989072 ↗
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- Nalu Medical, Inc. 71019-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall225 reports
- StimQ Receiver Stimulator Kit Channel A US w/Receiver STQ4-RCV-A0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)3 deaths270 reports
- Nalu Medical, Inc. 71020-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)213 reports
- StimQ Spare Lead Kit Channel B US w/Receiver STQ4-SPR-B0Stimwave Technologies Incorporated · Stimulator, Peripheral Nerve, Implanted (Pain Relief)126 reports
- Nalu Medical, Inc. 71005-USNalu Medical, Inc. · Stimulator, Peripheral Nerve, Implanted (Pain Relief)1 recall73 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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