Bivona 755170Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312006476), received between Jun 21, 2018 and Oct 23, 2021 — classified as 5 malfunctions.

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

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2021Break; Break

  IT WAS REPORTED THAT THE CUFF INFLATION PORT DEFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12686641 ↗
• MalfunctionAug 2, 2021Gas/Air Leak; Gas/Air Leak

  CUFF LEAK.

  Patient problems: Insufficient Information

  MAUDE report 12263510 ↗
• MalfunctionJun 21, 2018Air Leak; Air Leak

  IT WAS REPORTED THREE TRACHEOTOMY CANNULAS WITH THE SAME LOT NUMBER PRESENTED AN ISSUE WHERE THE BALLOONS WOULD DEFLATE APPROXIMATELY 7 TO 20 DAYS AFTER USE. THE NURSE SOMETIMES NEEDED TO RE- INFLATE EVERY HOUR. THERE WERE NO REPORTED CONSEQUENCES TO HEALTH OBSERVED FOR THE PATIENT. ONLY DISCOMFORT FOR THE PATIENT WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626556 ↗
• MalfunctionJun 21, 2018Air Leak; Air Leak

  IT WAS REPORTED THREE TRACHEOTOMY CANNULAS WITH THE SAME LOT NUMBER PRESENTED AN ISSUE WHERE THE BALLOONS WOULD DEFLATE APPROXIMATELY 7 TO 20 DAYS AFTER USE. THE NURSE SOMETIMES NEEDED TO RE- INFLATE EVERY HOUR. THERE WERE NO REPORTED CONSEQUENCES TO HEALTH OBSERVED FOR THE PATIENT. ONLY DISCOMFORT FOR THE PATIENT WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626540 ↗
• MalfunctionJun 21, 2018Air Leak; Air Leak

  IT WAS REPORTED THREE TRACHEOTOMY CANNULAS WITH THE SAME LOT NUMBER PRESENTED AN ISSUE WHERE THE BALLOONS WOULD DEFLATE APPROXIMATELY 7 TO 20 DAYS AFTER USE. THE NURSE SOMETIMES NEEDED TO RE- INFLATE EVERY HOUR. THERE WERE NO REPORTED CONSEQUENCES TO HEALTH OBSERVED FOR THE PATIENT. ONLY DISCOMFORT FOR THE PATIENT WAS NOTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7626537 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.