Nalu Medical, Inc. 71004-US (UDI 00812537030517)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
- 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 00812537030517), received between Aug 19, 2020 and Jul 19, 2022 — classified as 2 injuries.
The most frequently reported specific device problem is “Migration” (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
- Appropriate Device Problem Term/Code Not Available1
- Migration1
Patient problems
- Inadequate Pain Relief1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 19, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ON (B)(6) 2022 NALU BECAME AWARE THAT A NALU SYSTEM WAS EXPLANTED. ON (B)(6) 2021 XRAYS CONFIRMED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) HAD FLIPPED AND COMMUNICATION BETWEEN THE IPG AND THE EXTERNAL THERAPY DISC WAS NOT WELL MAINTAINED. NALU REPRESENTATIVE CONDUCTED A FOLLOW UP TO DETERMINE THE STATUS OF THE PATIENT AND WAS INFORMED ON (B)(6) 2022 THAT THE PATIENT WAS EXPLANTED AND REIMPLANTED WITH A DIFFERENT, NON-NALU SYSTEM. DATE OF EXPLANT AND FURTHER OUTCOME IS UNKNOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15059229 ↗InjuryAug 19, 2020Migration; Migration
ON (B)(6) 2020, PHYSICIAN REMOVED LEADS FROM THE PATIENT'S EPIDURAL SPACE, AND COILED THEM NEAR THE IMPLANTABLE DEVICE. THE PHYSICIAN PERFORMED A RE-IMPLANTATION OF THE LEADS ON (B)(6) 2020.
Patient problems: Inadequate Pain Relief
MAUDE report 10426971 ↗
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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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