Nalu Medical, Inc. 71001-USRecalls & reported problems
Nalu Medical, Inc. · Nalu Neurostimulation Kit (Integrated, Single 8, 40 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00812537030937), received between Mar 23, 2025 and Mar 23, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Device Unsafe to Use in Environment” (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
- Device Unsafe to Use in Environment1
Patient problems
- Inadequate Pain Relief1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2025Device Unsafe to Use in Environment; Device Unsafe to Use in Environment
THE PATIENT WAS IMPLANTED WITH A NALU PERIPHERAL NERVE STIMULATOR SYSTEM ON (B)(6)2019 TO TREAT FOOT PAIN. THE NALU SYSTEM WAS IMPLANTED AND IN USE FOR MORE THAN 5 YEARS WHEN THE FIRM WAS NOTIFIED THAT THE PATIENT WAS REQUESTING AN EXPLANT. PER THE PHYSICIAN, THE PATIENT NEEDS AN MRI AND THE SYSTEM THAT WAS IMPLANTED IS NOT MRI CONDITIONAL. ON (B)(6)2025 A REPRESENTATIVE FROM NALU WAS ABLE TO MAKE CONTACT WITH THE PATIENT AND DISCOVERED THAT THE EXPLANT HAD TAKEN PLACE IN (B)(6) 2024 AND WAS DONE DUE TO INADEQUATE PAIN RELIEF. FOLLOW-UP WITH THE PHYSICIAN FOUND THAT THE DATE OF EXPLANT WAS (B)(6)2024 AND THE PHYSICIAN'S OFFICE NOTED THAT THE PRIMARY REASON FOR EXPLANT WAS THE NEED FOR MRI. THE PHYSICIAN NOTED THAT, SECONDARY TO MRI NEEDS, THE PATIENT WAS NOT ABLE TO ACHIEVE GREATER THAN 50% PAIN RELIEF FROM THE SYSTEM DURING THE TIME IT HAD BEEN IMPLANTED.
Patient problems: Inadequate Pain Relief
MAUDE report 21673435 ↗
Other Stimulator, Peripheral Nerve, Implanted (Pain Relief) devices
- Quattrode™ 3166St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)429 reports
- Quattrode™ 3169St. Jude Medical, Inc. · STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)401 reports
- PNS Freedom Permanent Tined Neurostimulator Receiver Kit Channel A STQ4-RCV-A0Curonix LLC · Stimulator, Peripheral Nerve, Implanted (Pain Relief)8 deaths364 reports
- 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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