Nalu Medical, Inc. 72003-US (REF 72003)Recalls & reported problems
Nalu Medical, Inc. · Trial Lead Kit (8 contact, 60 cm) · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00812537030555), received between Sep 21, 2026 and Sep 29, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “High impedance” (2 reports).
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
- High impedance2
- Insufficient Device Problem Information1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Post Operative Wound Infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 29, 2026Insufficient Device Problem Information
Patient problems: Post Operative Wound Infection
MAUDE report 50938337 ↗MalfunctionSep 21, 2026High impedance
It was reported that during trial procedure, both leads were showing red ohms. Both leads were wiped multiple times, The Electrode Interfacing Cable (EIC) and EIC extension were swapped and issue persisted. New leads were opened, and the red ohms cleared.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842915 ↗MalfunctionSep 21, 2026High impedance
It was reported that during trial procedure, both leads were showing red ohms. Both leads were wiped multiple times, The Electrode Interfacing Cable (EIC) and EIC extension were swapped and issue persisted. New leads were opened, and the red ohms cleared.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50842912 ↗
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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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