Nalu Medical, Inc. 72013-USRecalls & reported problems

Nalu Medical, Inc. · Trial Lead Kit (4 contact, 40 cm) · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00812537036175), received between Jul 10, 2024 and Sep 23, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Impedance Problem” (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.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Impedance Problem1
Migration1

Patient problems

No Clinical Signs, Symptoms or Conditions1
Post Operative Wound Infection1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionSep 23, 2026Impedance Problem
The Nalu Sales Representative (rep) reported that when the physician placed an EIC on the lead, that all contacts showed bad impedances. Troubleshooting was done and the lead continued to show bad impedances. The Clincial Programmer app was restarted and there were now only a couple of contacts that were bad and programing was attempted. The patient was not feeling the stimulation, and the physician repositioned the lead. The physician removed the lead and put it in the other port, and as he did, the top of the ESC snapped in two, and a new one was used. The case continued with new lead and a new EIC and the case was completed without issue.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50867030 ↗
InjuryJul 10, 2024Migration; Migration
ON (B)(6) 2024 THE PATIENT BEGAN THE TRIAL PHASE FOR A NALU PERIPHERAL NERVE STIMULATOR SYSTEM, PER THE PATIENT, STIMULATION FROM THE SYSTEM CEASED ON (B)(6) 2024 THE PATIENT WOKE UP FROM BED WITH FOUL SMELLING DRAINAGE AT THE INCISION SITE. PATIENT PRESENTED TO THE LOCAL EMERGENCY DEPARTMENT ON (B)(6) 2024 AND WAS ADMITTED TO THE ACUTE FACILITY FOR IV ANTIBIOTICS. THE FIRM WAS NOT NOTIFIED OF THE LOSS OF THERAPY, DRAINAGE, OR HOSPITALIZATION UNTIL (B)(6) 2024 WHEN THE PATIENT CALLED A NALU REPRESENTATIVE. PER THE PATIENT, THE TEMPORARY LEADS "FELL OUT ON THEIR OWN". THE DATE OF THE LEADS COMING OUT IS UNKNOWN.
Patient problems: Post Operative Wound Infection
MAUDE report 19717040 ↗

Device details

UDI-DI	`00812537036175`
Brand	Nalu Medical, Inc.
Model	72013-US
Company	Nalu Medical, Inc.
Product code	GZF · Stimulator, Peripheral Nerve, Implanted (Pain Relief)
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	Jul 16, 2026

Device type (GMDN): Trial spinal cord/peripheral nerve percutaneous analgesic electrical stimulation system lead

An invasive, electrically-insulated wire with a distal electrode intended to be introduced into the epidural space of the spinal cord and/or in/near a peripheral nerve (e.g., lumbar, truncal, in a limb) for percutaneous wired transmission of electrical impulses from an external pulse generator, to the target nerves, for analgesia during a trial period (<= 30 days). It is designed to validate therapy/test operating parameters prior to introduction of a permanent implantable analgesic electrical stimulation system.

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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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