Sunmed 1-7333-75Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10889483001813), received between Mar 21, 2025 and Jul 24, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 24, 2025Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED, THE PATIENT WAS PLACED ON THE VENTILATOR AFTER INTUBATION, LOW VOLUMES AND HIGH PEAK PRESSURES WAS OBSERVED. AN UNSUCCESSFUL ATTEMPT WAS MADE TO RESOLVE THE ISSUE WITH MEDICAL INTERVENTION. HOWEVER, THE SUCTION CATHETER WOULD NOT PASS, THEREFORE BRONCHOSCOPY WAS ATTEMPTED TO OBSERVE THE OBSTRUCTION; THE MEDICAL PROFESSIONAL COULD NOT PASS THE BRONCHOSCOPY THROUGH THE TUBE. THE PATIENT WAS EXTUBATED AND REINTUBATED WITH A DIFFERENT ENDOTRACHEAL TUBE (ETT). IT WAS ADDITIONALLY REPORTED, THE ORIGINAL ETT WAS OBSERVED TO BE KINKED (IT WAS NOT KINKED PRIOR TO INTUBATION AND WAS STYLETED WITH A RIGID STYLET). IT WAS ADDITIONALLY REPORTED, THAT THE PATIENT DID NOT BITE THE TUBE ON OR AFTER INTUBATION; A MILD TEMPORARY (UNSPECIFIED) HARM WAS SUSTAINED BY PATIENT.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 22591472 ↗
• MalfunctionMar 21, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN ENDOTRACHEAL TUBE CUFF LEAKED WHICH RESULTED IN AN UNSECURED AIRWAY, NECESSITATING REINTUBATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21670719 ↗

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, Classified
  SunMed Tracheal Tube, Size 2.5; Model Number: 1-7333-25