NIM 8229307 (UDI 00763000882396)Recalls & reported problems
Medtronic Xomed, Inc. · EMG TUBE 8229307 NIM STD 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
- 7
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000882396), received between May 21, 2024 and Feb 24, 2026 — classified as 7 malfunctions.
The most frequently reported specific device problem is “Unintended Deflation” (6 reports).
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
- Unintended Deflation6
- Failure to Unfold or Unwrap1
- Incorrect, Inadequate or Imprecise Result or Readings1
- Physical Resistance/Sticking1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Unintended Extubation1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Incorrect, Inadequate or Imprecise Result or Readings; Unintended Deflation
IT WAS REPORTED THAT DURING INTRA-OP, AFTER CONNECTION, THE MAIN UNIT DISPLAYED A SELF-TEST FAILURE. RECONNECTION WAS PERFORMED, BUT THE DEVICE REMAINED UNRESPONSIVE. REPLACING THE TUBE WITH THE NEW ONE RESOLVED THE ISSUE, LEADING TO THE CONCLUSION THAT THE TUBE HAD POOR CONTACT AND WAS UNUSABLE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24438688 ↗MalfunctionMay 9, 2025Failure to Unfold or Unwrap; Unintended Deflation; Failure to Unfold or Unwrap; Unintended Deflation
IT WAS REPORTED THAT DURING PRE OP IT WAS FOUND THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL BEFORE SURGERY. THE PROCEDURE WAS COMPLETED WITH BACK UP DEVICE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21991429 ↗MalfunctionMay 6, 2025Physical Resistance/Sticking; Physical Resistance/Sticking
IT WAS REPORTED DURING PRE-OP THAT THE CUFF OF THE ENDOTRACHEAL TUBE WAS ADHERED TO THE TUBE WALL. PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21966162 ↗MalfunctionMay 5, 2025Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT FOR THYROID SURGERY, WHEN THE NERVE MONITORING ENDOTRACHEAL TUBE WAS UNPACKED, THE CUFF WAS FOUND TO BE LEAKING AIR AND IT COULD NOT BE USED. THE LEAK TEST WAS PERFORMED, INFLATED THE CUFF WITH THE 5 ML SYRINGE AND THE AIR LEAKAGE WAS FOUND. REPLACED WITH ANOTHER ENDOTRACHEAL TUBE TO COMPLETE THE SURGERY. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21958027 ↗MalfunctionMay 4, 2025Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT PRE-OP, THE CUFF OF THE ENDOTRACHEAL TUBE WAS FOUND TO BE LEAKING AIR BEFORE SURGERY. 5ML OF AIR WAS USED TO INFLATE THE CUFF WITH SYRINGE. PROCEDURE WAS COMPLETED WITH ANOTHER PRODUCT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21957673 ↗MalfunctionApr 1, 2025Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT DURING THE PRE-INFLATION OF THE ENDOTRACHEAL TUBE BEFORE SURGERY, IT WAS FOUND THAT THE CUFF WAS LEAKING AND COULD NOT BE USED NORMALLY. THE PROBLEM WAS SOLVED AFTER REPLACING THE ENDOTRACHEAL TUBE WITH A NEW ONE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21736455 ↗MalfunctionMay 21, 2024Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT INTRA-OP DURING THYROIDECTOMY PROCEDURE, ABOUT 5 MINUTES AFTER INTUBATION, THE ANESTHETIC FOUND THE AIR LEAK FROM CUFF. SO, THE ANESTHETIC CHANGED A NEW ENDOTRACHEAL TUBE. THERE WAS NO DAMAGE OBSERVED IN THE PACKAGING. THERE WAS NO PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 19358709 ↗
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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