Nalu Medical, Inc. 23003-060-US (UDI 00812537030142)Recalls & reported problems
Nalu Medical, Inc. · Tearaway introducer assembly (14 cm sheath) · Class 2
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 00812537030142), received between Sep 25, 2019 and Sep 25, 2019 — classified as 1 injury.
The most frequently reported specific device problem is “Use of Device 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.
Most reported problems
Device problems
- Use of Device Problem1
Patient problems
- Cerebrospinal Fluid Leakage1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 25, 2019Use of Device Problem; Use of Device Problem
THE PATIENT UNDERWENT SCS IMPLANT SURGERY ON (B)(6) 2019. DURING THE SURGERY THE SURGEON, DR. (B)(6) NOTICED THAT THE PATIENT HAD FLUID LEAKAGE AND SUSPECTED THAT THE PATIENT HAD A CEREBROSPINAL FLUID (CSF) LEAK. THE PATIENT REPORTED HEADACHE AND DIZZINESS SYMPTOMS POST-SURGERY. THE PHYSICIAN CONFIRMED THAT THE PATIENT HAD A CSF LEAK. WHILE THE PATIENT WAS RECOVERING FROM SURGERY, DR. (B)(6) SAW THE PATIENT ON (B)(6) FOR THE SCHEDULED POST IMPLANT FOLLOW UP AND INITIAL PROGRAMMING. DR. (B)(6) ALSO USED THIS APPOINTMENT TO EVALUATE THE HEADACHE AND DIZZINESS SYMPTOMS AND DETERMINED THAT NO BLOOD PATCH WAS NEEDED. THE PATIENT WAS RELEASED FROM THE HOSPITAL ON (B)(6) 2019. ON (B)(6) THE PATIENT SAW DR. (B)(6) FOR A PROGRAMMING FOLLOW UP AND TO RE-EVALUATE THE PATIENT'S SYMPTOMS. THE PATIENT'S ISSUES RELATED TO THE CSF LEAK HAD ALMOST COMPLETELY RESOLVED, AND THE PATIENT ONLY HAD MINOR DIZZINESS. THE PATIENT CAME IN FOR THEIR NEXT SCHEDULED VISIT ON (B)(6). AT THIS VISIT THE PATIENT REPORTED THEY NO LONGER HAD ANY CSF LEAK SYMPTOMS AND ARE RECEIVING GREAT PAIN THERAPY.
Patient problems: Cerebrospinal Fluid Leakage
MAUDE report 9119554 ↗
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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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