NIM 8229507Recalls & reported problems
Medtronic Xomed, Inc. · EMG TUBE 8229507 NIM CONT 7MM 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
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000882426), received between May 27, 2024 and Mar 13, 2025 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Failure to Deflate” (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-1519-2022 · Root cause: Under Investigation by firm · FDA record ↗
Most reported problems
Device problems
- Failure to Deflate1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Airway Obstruction1
- Unintended Extubation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 13, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
IT WAS REPORTED THAT THE ENDOTRACHEAL TUBE DOES NOT RECOGNIZE VOCAL ON THE NEURO MONITOR. THE MONITOR WAS RESTARTED SEVERAL TIMES WITHOUT SUCCESS. THE ENDOTRACHEAL TUBE WAS ROTATED SEVERAL TIMES WITHOUT SUCCESS. THERE WAS NO PATIENT IMPACT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21593922 ↗MalfunctionJun 21, 2024Failure to Deflate; Failure to Deflate
IT WAS REPORTED THAT WHEN CHECKING THE PATENCY OF THE CUFF BEFORE THE PROCEDURE, THE ANESTHETIST WAS UNABLE TO DEFLATE THE CUFF. THE ISSUE OCCURRED AS OUT OF BOX, FIRST USE FAILURE. THE CUFF CAME INFLATED AND WOULD NOT DEFLATE. ANOTHER TUBE WAS USED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19580320 ↗InjuryMay 27, 2024Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING RIGHT HEMI THYROIDECTOMY ANESTHESIOLOGIST STATED TUBE BLOCKED PATIENTS AIRWAY AND NEEDED TO REDO THE INT UBATION. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. PATIENT ALIVE WITH NO INJURY.
Patient problems: Airway Obstruction; Unintended Extubation
MAUDE report 19399284 ↗
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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