Bivona 67PFSS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 166 adverse event reports that list this exact device (DI 10351688518682), received between Apr 12, 2017 and Sep 29, 2026 — classified as 32 injuries, 134 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (97 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K923878); 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.

Recalls naming this device

1. May 29, 2024Open, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 166 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Separation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50939873 ↗
• MalfunctionApr 15, 2026Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE PATIENT DID NOT HAVE ANY CONDITION THAT CAUSED CONVULSIONS OR SEIZURES. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24888750 ↗
• MalfunctionApr 15, 2026Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THE PATIENT DID NOT HAVE ANY CONDITION THAT CAUSED CONVULSIONS OR SEIZURES. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24887530 ↗
• MalfunctionFeb 2, 2026Material Deformation

  IT WAS STATED THAT THE BALLOON WAS NOT EXPANDING, LEAVING THE WATER REMAINED IN THE CUFF. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND THERE WAS NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24238384 ↗
• MalfunctionDec 8, 2025Break; Break

  IT WAS REPORTED THAT THE FLEX TRACH WIRE WAS EXPOSED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AT PATIENT'S HOME. THE OUTCOME OF THE EVENT WAS ON GOING AND AWAITING FOR REPLACEMENT. THE CHILD WAS VENT DEPENDENT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745611 ↗
• MalfunctionDec 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS INFLATED TO CHECK PATENCY AND WAS FULLY INFLATED APPROPRIATELY. THE PATIENT REMAINED AGITATED, SO ANOTHER TRACH CHANGE WAS PERFORMED. THE REMOVED TRACH WAS INSPECTED, AND WHEN THE CUFF WAS REINFLATED, THE BALLOON WAS FOUND TO INFLATE ONLY ON ONE SIDE. THERE WAS NO HARM OCCURRED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23687005 ↗
• MalfunctionDec 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A TRACH CHANGE, THE BALLOON WAS INITIALLY INFLATED TO CONFIRM PATENCY AND FULLY INFLATED AS EXPECTED. AFTER PLACEMENT, THE PATIENT REMAINED AGITATED, PROMPTING AN ADDITIONAL TRACH CHANGE. UPON INSPECTION OF THE REMOVED TRACH, REINFLATION OF THE CUFF SHOWED THAT THE BALLOON INFLATED ONLY ON ONE SIDE. NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23682593 ↗
• MalfunctionNov 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. PATIENT INVOLVEMENT WAS NOTED; HOWEVER, IT IS UNCLEAR WHETHER THE EVENT OCCURRED DURING PRE-USE TESTING OR DURING ACTUAL PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532472 ↗
• MalfunctionNov 12, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON FAILED TO INFLATE. PATIENT INVOLVEMENT WAS NOTED; HOWEVER, IT IS UNCLEAR WHETHER THE EVENT OCCURRED DURING PRE-USE TESTING OR DURING ACTUAL PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23532369 ↗
• MalfunctionAug 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE DID NOT INFLATE. THERE WAS PATIENT INVOLVEMENT, NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804841 ↗
• MalfunctionJul 28, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22632366 ↗
• MalfunctionApr 4, 2025Break; Break

  IT WAS REPORTED THAT THE FLANGE WAS BROKEN IN THE BILATERAL DIRECTION. THERE WAS UNKNOWN PATIENT HARM REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21778001 ↗
• MalfunctionApr 1, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE DID NOT INFLATE. THEY DID NOT USE IT ON A PATIENT AFTER THEY DISCOVERED THE DEFECT. THERE WAS NO PATIENT HARM OR ADVERSE EVENT REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21748411 ↗
• MalfunctionMar 26, 2025Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE WAS DEFLATING. THE EVENT OCCURRED DURING TESTING BY NURSE. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21698439 ↗
• InjuryMar 25, 2025Degraded; Unintended Deflation; Degraded; Unintended Deflation

  IT WAS REPORTED THAT THE TRACH WAS IN PLACE, AND THERE WAS A CONCERN FOR CUFF LEAK DUE TO CUFF FOUND AT 0.5ML INSTEAD OF 1 ML MULTIPLE TIMES IN 1 WEEK. TRACH WAS SUBSEQUENTLY CHANGED. UPON THE CHANGE, THE TRACH WAS INSPECTED, AND THE CUFF WAS FOUND TO BE ROUGH/WARN OUT/DEGRADED TO TOUCH. NO ACTIVE LEAKAGE NOTED. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. A NEW TRACH TUBE WAS PLACED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21690247 ↗
• MalfunctionMar 24, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD NOT INFLATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21676679 ↗
• MalfunctionFeb 11, 2025Inflation Problem; Mechanical Problem; Inflation Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE BALLOON FAILED WOULD NOT FUNCTION. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21356728 ↗
• MalfunctionJan 10, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON THE TRACH WILL NOT INFLATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21125173 ↗
• MalfunctionJan 6, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON/CUFF WOULDN'T INFLATE WITH AIR/WATER. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21079681 ↗
• MalfunctionDec 26, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE CUFF PILOT BALLOON WAS NOTED AS BROKEN ON TEST INFLATION. THE ONE-WAY VALVE WAS WEDGED. THERE WAS PATIENT INVOLVEMENT WITH NO HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21019682 ↗
• MalfunctionNov 20, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20739136 ↗
• MalfunctionNov 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ITSELF DID NOT INFLATE. SHE OPENED ANOTHER TRACH AND LUCKILY IT WOULD FULLY INFLATE. THE TRACH THAT LASTED 24 HOURS WAS TAKEN OUT AND SHE REINFLATED THE CUFF AND ONLY ONE SIDE OF THE CUFF WOULD INFLATE. HER DAUGHTER GONE THROUGH THREE TRACHES IN LESS THAN 72 HOURS. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20690231 ↗
• MalfunctionNov 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON FILLED, BUT THE CUFF ITSELF DID NOT INFLATE. SHE OPENED ANOTHER TRACH AND LUCKILY IT WOULD FULLY INFLATE. THE TRACH THAT LASTED 24 HOURS WAS TAKEN OUT AND SHE REINFLATED THE CUFF AND ONLY ONE SIDE OF THE CUFF WOULD INFLATE. HER DAUGHTER GONE THROUGH THREE TRACHES IN LESS THAN 72 HOURS. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689932 ↗
• InjuryNov 14, 2024Inflation Problem; Inflation Problem

  IT WAS STATED THAT THE PATIENT'S PARENTS PERFORMED PRE-TESTING THE OF THE DEVICE AND FOUND THAT THE CUFF DID NOT EXPAND. THEY ATTEMPTED A TOTAL OF TRACHES FOR THEIR DAUGHTER IN LESS THAN 72 HOURS. ONE OF DEVICES EVENTUALLY WORKED AND LASTED FOR 24 HOURS. HOWEVER, WITH THIS SAID DEVICE, ONLY ONE SIDE OF THE CUFF INFLATED EVENTUALLY. PATIENT IS A 19-MONTH-OLD FEMALE. THERE WAS MEDICAL INTERVENTION REQUIRED, AND AN INCREASE OF OXYGEN FLOW WAS FOUND. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689573 ↗
• MalfunctionOct 22, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT HAD AN AUDIBLE LEAK ON THEIR TRACHEOSTOMY TUBE. THERE WERE LOW MINUTE VOLUMES. A TUBE CHANGE WAS PERFORMED. THERE WAS PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20507064 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.