Nalu Medical, Inc. 71005-US (UDI 00812537030524)Recalls & reported problems
Nalu Medical, Inc. · Nalu Neurostimulation Kit (Ported, Dual 8, 40 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812537030524), received between Aug 17, 2021 and Nov 22, 2024 — classified as 2 injuries.
1 FDA recall record name this device's identifier, 1 still open.
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
Recalls naming this device
- Jun 3, 2024Class IIOpen, Classified
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
Z-2257-2024 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS IMPLANTED WITH A NALU SPINAL CORD STIMULATOR SYSTEM ON (B)(6) 2020. ON (B)(6) 2024 THE FIRM WAS NOTIFIED THAT A FULL SYSTEM EXPLANT HAD TAKEN PLACE ON (B)(6) 2024 PER THE PATIENT'S REQUEST. INFORMATION RECEIVED INDICATES THAT THE PATIENT'S PAIN SYMPTOMS WERE BEING ADEQUATELY MANAGED WITHOUT USING THE NALU DEVICE AND SO THE PATIENT NO LONGER WANTED TO KEEP THE DEVICE. NO NALU REPRESENTATIVES WERE PRESENT AT THE EXPLANT AND THE FIRM WAS NOTIFIED ON 10/23/2024 THAT THE PROCEDURE HAD TAKEN PLACE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20762029 ↗InjuryAug 17, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
ON X-RAY, IT WAS FOUND THAT THE IPG MIGRATED CAUSING LOSS OF COMMUNICATION WITH THE THERAPY DISCS. REVISION TO MOVE THE IPG WAS PERFORMED. THE ORIGINAL IMPLANT WAS MOVED TO A NEW POCKET. NO FURTHER COMMUNICATION ISSUES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12333354 ↗
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 · each recall links to the FDA recall notice
- 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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