Bivona 67HA90Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312013825), received between Apr 5, 2019 and Oct 13, 2022 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K081440); 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 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PRODUCT, THE NURSE READ THE PRODUCT INSTRUCTION FOR USE (IFU) AND COMPARED THE ENGLISH TEXT TO THE FINNISH TEXT AND NOTICED THAT THE TRANSLATION WAS NOT CORRECT, OBSERVED WITH FOUR LOT NUMBERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598944 ↗
• InjuryNov 11, 2019Leak/Splash; Scratched Material; Leak/Splash; Scratched Material

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE WAS FOUND TO BE BROKEN AND LEAKING. THE PRODUCT WAS REMOVED AND RETURNED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9305875 ↗
• InjuryNov 11, 2019Leak/Splash; Scratched Material; Leak/Splash; Scratched Material

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL BIVONA® ADULT TTS¿ HYPERFLEX¿ TRACHEOSTOMY TUBE WAS FOUND TO BE BROKEN SIX HOURS AFTER USE. IT WAS REPORTED THAT THE TUBE HAD BEEN REMOVED FOR REPOSSESSING PRIOR TO REINSERTION. THE TRACH TUBE WAS REMOVED AND RETURNED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9304976 ↗
• MalfunctionApr 5, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY TUBE WAS IN USE, THE PATIENT EXPERIENCED A LOSS OF VENTILATION DUE TO A CUFF LEAK. THE SALINE LOSS WAS SEEN IN THE BRONCHIAL TUBE VISUALIZED WITH FIBROSCOPIC COLUMN. NO FURTHER ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8488775 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081440. One submission often covers many models, so check the product and lot details in each record.

• Z-2485-2020 · May 26, 2020 · Terminated
  Pediatric Adjustable Flange Tracheostomy Tube Cuffless