NIM 8229308 (UDI 00763000745837)Recalls & reported problems
Medtronic Xomed, Inc. · EMG TUBE 8229308 NIM STD 8MM 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 00763000745837), received between Apr 8, 2024 and Jul 22, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Unintended Deflation” (2 reports).
1 FDA recall record name this device's identifier, 1 still open.
2 other recalls cover devices cleared under the same FDA submission (K925640); they may or may not involve this specific model.
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 Deflation2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Unintended Extubation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJul 22, 2024Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT THE NIM TUBE USED TO INTUBATE PATIENT MALFUNCTIONED INTRAOPERATIVELY. THE AIR BEGAN LEAKING AROUND THE CUFF OF THE TUBE, REQUIRING REPLACEMENT. THERE WAS NO KNOWN PATIENT IMPACT.
Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Extubation
MAUDE report 19790137 ↗MalfunctionApr 8, 2024Unintended Deflation; Unintended Deflation
IT WAS REPORTED THAT PRE OP THE ANESTHESIA PROVIDER INFLATED THE CUFF TO TEST IT PRIOR TO THE PATIENT COMING INTO THE OPERATING ROOM. THE CUFF WOULD NOT DEFLATE. THERE IS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19060714 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K925640. One submission often covers many models, so check the product and lot details in each record.
- Z-0901-2017 · Jun 28, 2016 · TerminatedNIM EMG Endotracheal Tube, 6.0 mm I.D. x 8.8 mm O.D. (27 FR), Reinforced, Sterile, Rx only. Individually packaged.
- Z-0310-05 · Oct 29, 2004 · TerminatedBrand name: NIM EMG Endotracheal Tube REF 82-29106, 82-29107, 82-29108 NIM EMG Reinforced Endotracheal Tube REF 82-29306, 82-
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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