Nalu Medical, Inc. 71004-US (UDI 00812537030968)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 00812537030968), received between Sep 3, 2021 and Sep 3, 2021 — 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
- Migration1
- Patient-Device Incompatibility1
Patient problems
- Blister2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2021Patient-Device Incompatibility; Patient-Device Incompatibility
PATIENT NOTICED A BLISTER AT THE SITE OF A RECENT REVISION. HE WENT TO SEE PHYSICIAN ON (B)(6) 2021. PHYSICIAN DRAINED THE BLISTER. PATIENT ALSO REPORTED HEAT AT THE SITE. PATIENT IS KNOWN TO HAVE A REACTION TO THE ADHESIVE CLIPS.
Patient problems: Blister
MAUDE report 12425653 ↗InjurySep 3, 2021Migration; Migration
ON (B)(6) 2021 PATIENT HAD HIS IMPLANT REVISED AND MOVED TO NEW LOCATION TO REPOSITION THE DEVICE.
Patient problems: Blister
MAUDE report 12425601 ↗
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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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