NIM 8229306 (UDI 00763000882389)Recalls & reported problems
Medtronic Xomed, Inc. · EMG TUBE 8229306 NIM STD 6MM ROHS · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000882389), received between Feb 10, 2025 and May 12, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Gas/Air Leak” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Recalls naming this device
- Apr 29, 2022Open, Classified
The firm received reports of events related to airway obstruction while using NIM Standard Reinforced EMG Endotracheal Tubes & NIM CONTACT Reinforced EMG Endotracheal Tubes.
Z-1520-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Gas/Air Leak1
- Unintended Deflation1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Unintended Extubation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 12, 2025Gas/Air Leak; Gas/Air Leak
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE BEFORE PERFORMING THYROID SURGERY ENDOTRACHEAL TUBE WAS CHECKED AND FOUND NO PROBLEMS. AFTER THE PATIENT WAS ANESTHETIZED AND INTUBATED, IT WAS FOUND THAT THE CUFF WAS LEAKING. CUFF WAS INFLATED WITH 4 ML OF AIR WITH 5 ML SYRINGE. INTRA CUFF PRESSURE WAS NOT MONITORED. THE PATIENT HAD A HUGE GOITER AND THE TRACHEA WAS COMPRESSED, BUT THE VENTILATION WAS NORMAL. ANOTHER ENDOTRACHEAL TUBE WAS REPLACED TO ENSURE THE SMOOTH PROGRESS OF THE OPERATION. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: Unintended Extubation
MAUDE report 22004736 ↗MalfunctionFeb 10, 2025Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT PRIOR TO USE, THE CUFF WAS LEAKING AND COULD NOT BE USED NORMALLY. THE CASE WAS THYROID CANCER SURGERY. REPLACED THE NEW ENDOTRACHEAL TUBE TO COMPLETE THE OPERATION. CUFF AND TUBE CHECKED PRIOR TO USE AND FOUND IT WAS LEAKING. 5ML SYRINGE SIZE WAS USED. AIR WAS USED TO INFLATE THE CUFF. EMG TUBE WAS USED FOR THE FIRST TIME. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21341422 ↗
Other STIMULATOR, NERVE devices
- NIM Vital NIM4CM01Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls260 reports
- NIM TriVantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls176 reports
- NIM® 8229306Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall1 death167 reports
- NIM Vital™ NIM4CPB1Medtronic Xomed, Inc. · STIMULATOR, NERVE3 recalls45 reports
- NIM Trivantage® 8229707Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall142 reports
- NIM® 8229307Medtronic Xomed, Inc. · STIMULATOR, NERVE1 recall138 reports
- NIM TriVantage® 8229706Medtronic Xomed, Inc. · STIMULATOR, NERVE2 recalls78 reports
- NIM-Response® 8253002Medtronic Xomed, Inc. · STIMULATOR, NERVE171 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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