NIM Essence NIMEID070Recalls & reported problems
Medtronic Xomed, Inc. · ESSENCE EMG TUBE NIMEID070 5PK 7MM CE · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000821791), received between Aug 7, 2026 and Aug 13, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Difficult to Insert” (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.
Reports received per month
Most reported problems
Device problems
- Difficult to Insert1
- Inappropriate Audible Prompt/Feedback1
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 13, 2026Inappropriate Audible Prompt/Feedback
It was reported that during use, the NIM essence endotracheal tube once connected to the NIM monitor created continuous noise and procedure abandoned on one patient. There was no patient impact.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50231713 ↗MalfunctionAug 7, 2026Difficult to Insert; Incorrect, Inadequate or Imprecise Result or Readings
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50169808 ↗
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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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