Nalu Medical, Inc. 71004 (UDI 00812537036083)Recalls & reported problems
Nalu Medical, Inc. · Nalu IPG Kit (Ported, Dual 8) · 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 00812537036083), received between Mar 29, 2023 and Mar 29, 2023 — classified as 1 injury.
The most frequently reported specific device problem is “Device-Device Incompatibility” (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
Device problems
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 29, 2023Device-Device Incompatibility; Device-Device Incompatibility
ON (B)(6) 2023 NALU BECAME AWARE OF A SURGICAL PROCEDURE THAT TOOK PLACE ON (B)(6) 2023. A NALU PERIPHERAL NERVE STIMULATOR SYSTEM WAS FULLY EXPLANTED DUE TO THE PATIENT NEED FOR AN MRI PRIOR TO AN UNRELATED SURGICAL PROCEDURE. THERE ARE NO COMPLAINTS OF SYSTEM OR COMPONENT FAILURE OR MEDICAL CONDITIONS RELATING TO THE NALU PRODUCT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16634968 ↗
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- 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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