Sunmed 1-7321-80Recalls & reported problems
Sunmed, LLC · PREFORMED ORAL CUFFED E/T TUBE 8mm 32FR · 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 10889483009079), received between Aug 2, 2024 and Nov 22, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
1 other recall cover devices cleared under the same FDA submission (K042683); 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. 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
- Material Integrity Problem1
- Material Twisted/Bent1
- Ventilation Problem in Device Environment1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- Sore Throat1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 22, 2024Ventilation Problem in Device Environment; Ventilation Problem in Device Environment
"THE TUBE TWISTED AND KINKED ON ITSELF DURING THE INSERTION. QUOTE FROM THE ANESTHESIOLOGIST: ""FROM WHAT I RECALL HE HAD A BIT OF A SORE THROAT ON WAKING UP, BUT THERE WAS NO FURTHER INJURY OR INTERVENTION APART FROM REINTUBATION. IT WAS A NEAR MISS THOUGH FOR A HYPOXEMIC ARREST."" THE PATIENT DESALTED TO 40% TO WHICH THE TUBE WAS REMOVED. "
Patient problems: Sore Throat
MAUDE report 20763360 ↗MalfunctionAug 2, 2024Material Integrity Problem; Material Twisted/Bent; Material Integrity Problem; Material Twisted/Bent
ALLOWED NO ROTATION AL ALL AND CERTAINLY NOT A 360 DEGREE ROTATION. IT KINKED IN THE BEND. IT IS TOO SOFT AND IT IS PRONE TO KINKING. INCIDENT OCCURRED DURING PT USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19897970 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K042683. One submission often covers many models, so check the product and lot details in each record.
- Z-3172-2026 · Jul 31, 2026 · Open, ClassifiedSunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25
Other Tube, Tracheal (W/Wo Connector) devices
- Shiley 18875Covidien LP · Tube, tracheal (w/wo connector)4 deaths570 reports
- RUSCH IPN041476Teleflex Incorporated · Tube, tracheal (w/wo connector)10 recalls0 reports
- Shiley 18775Covidien LP · Tube, tracheal (w/wo connector)489 reports
- Shiley 18770Covidien LP · Tube, tracheal (w/wo connector)2 deaths434 reports
- Shiley 18880Covidien LP · Tube, tracheal (w/wo connector)2 deaths370 reports
- Shiley 18780Covidien LP · Tube, tracheal (w/wo connector)3 deaths286 reports
- Shiley 18770SCovidien LP · Tube, tracheal (w/wo connector)273 reports
- Shiley 18780SCovidien LP · Tube, tracheal (w/wo connector)251 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 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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