MICROCUFF™ 35111Recalls & reported problems
Sunmed, LLC · MICROCUFF™ ENDOTRACHEAL TUBE FOR PEDIATRICS/Oral/Nasal Magill, Murphy Eye/Radiopaque · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10889483564981), received between Mar 5, 2026 and Mar 5, 2026 — classified as 1 injury.
The most frequently reported specific device problem is “Off-Label Use” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Off-Label Use1
Patient problems
- Pressure Sore/Ulcer1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 5, 2026Off-Label Use
IT WAS REPORTED THAT THEY ARE NOTICING A MARKED INCREASE IN THE INCIDENCE OF PRESSURE AREAS IN PATIENT'S NARES.
Patient problems: Pressure Sore/Ulcer
MAUDE report 24527659 ↗
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- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.