Bivona 67HA60Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15021312013795), received between Oct 13, 2022 and May 14, 2026 — classified as 3 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 14, 2026Leak/Splash

  IT WAS REPORTED THAT THE TRACH TUBE EXHIBITED A CUFF LEAKAGE DURING PATIENT USE. THE DEVICE WAS REPLACED AND THE ISSUE RESOLVED. UNKNOWN INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179457 ↗
• MalfunctionMar 13, 2025Break; Break

  IT WAS REPORTED THAT THE TRACH WAS DELIVERED IN A SEALED BOX, AND WHEN THE TRACH WAS OPENED AND INSERTED, IT WAS FOUND THAT THE BALLON HAD BEEN CUT OFF THE TRACH. THE TRACH WAS REMOVED, AND BACKUP WAS INSERTED. THIS HAPPENED AT THE PATIENT'S HOUSE WHILE IN USE WITH PATIENT. THERE WAS PATIENT INVOLVEMENT, AND THE EVENT AFFECTED PATIENT CARE. HOWEVER, THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596170 ↗
• MalfunctionSep 10, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT WHEN TRACH WAS OPENED AND INSERTED, IT WAS FOUND THAT THE BALLOON HAD BEEN CUT OFF THE TRACH. TRACH WAS REMOVED AND BACKUP INSERTED. THERE WAS MEDICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20185209 ↗
• InjuryFeb 9, 2023Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE BROKE WHILE IN USE WITH THE PATIENT. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND WAS MANUALLY VENTILATED. THE EVENT OCCURRED AFTER 25 DAYS OF USE.

  Patient problems: Hypoxia

  MAUDE report 16342514 ↗
• InjuryFeb 9, 2023Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE BROKE WHILE IN USE WITH THE PATIENT. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND WAS MANUALLY VENTILATED. THE EVENT OCCURRED AFTER 25 DAYS OF USE.

  Patient problems: Hypoxia

  MAUDE report 16342501 ↗
• InjuryFeb 9, 2023Break; Deflation Problem; Break; Deflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE BROKE WHILE IN USE WITH THE PATIENT. THE PATIENT EXPERIENCED RESPIRATORY DISTRESS AND WAS MANUALLY VENTILATED. THE EVENT OCCURRED AFTER 25 DAYS OF USE.

  Patient problems: Hypoxia

  MAUDE report 16342236 ↗
• 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 15597297 ↗

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