Bivona 67PFPS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10351688518569), received between May 16, 2018 and Apr 21, 2025 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 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. How this data works · Data updated Oct 13, 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-2612-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT FILLED WITH WATER AND THERE WAS A ONE-SIDE FILLING OF THE CUFF. MANIPULATION (RUNNING INSTRUCTIONS FOR USE (IFU)) ON THE FILLED OPPOSITE SIDE SHOWED NO IMPROVEMENT IN THE SITUATION. THE CUFF REMAINED UNFILLED ON ONE SIDE. THE EVENT OCCURRED DURING PRETEST. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21872991 ↗
• MalfunctionMay 9, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT WHILE INFLATING THE BALLOON, IT WAS SIGNIFICANTLY SMALLER WHEN HOLDING IT UP TO THE EXACT SAME SIZE TRACH AND IT WAS CAUSING IT TO SLIP OUT. THE ISSUE WAS DISCOVERED WHILE IN USE WITH THE PATIENT. THE OUTCOME OF THE EVENT; THEY REMOVED THE TRACH AND USED ANOTHER ONE. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19279479 ↗
• InjuryJun 14, 2023Detachment of Device or Device Component; Unintended Deflation; Detachment of Device or Device Component; Unintended Deflation

  IT WAS REPORTED THAT A RESPIRATORY THERAPIST (RT) WAS COMPLETING A PATIENT ASSESSMENT OF TRACHEOSTOMY TUBE BALLOON VOLUME. UPON ASSESSMENT THE CUFF WAS NOTED TO BE DEFLATED, AND RT FOUND THAT VALVE ON PILOT BALLOON WAS MISSING. PATIENT (PEDIATRIC) WAS CHEWING ON PILOT BALLOON AT TIME OF ASSESSMENT . THE RT WAS UNSURE IF THE PATIENT CHEWED VALVE OUT OF BALLOON OR IF IT FELL OUT AS RT WAS UNABLE TO LOCATE THE VALVE. TRACHEOSTOMY REPLACED.

  Patient problems: Insufficient Information

  MAUDE report 17128650 ↗
• MalfunctionOct 12, 2022Material Puncture/Hole; Tear, Rip or Hole in Device Packaging; Material Puncture/Hole; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE TECHNICIAN STATED UPON FIRST REPROCESSING, A HOLE WAS FOUND IN THE TRACH'S SHAFT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591511 ↗
• MalfunctionOct 12, 2022Defective Component; Defective Device; Defective Component; Defective Device

  IT WAS REPORTED THAT UPON PRE-TEST, THE TRACH WAS MALFUNCTIONING. NO FURTHER INFORMATION WAS KNOWN, AS DISTRIBUTOR REPORTED THIS THROUGH CLIENT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591510 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING DESPITE ADDING WATER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417373 ↗
• MalfunctionDec 23, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH TUBE WAS LEAKING AT THE SHAFT AND THE FLANGE. THERE WAS NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11070164 ↗
• MalfunctionDec 18, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH TUBE WAS LEAKING AT THE SHAFT AND THE FLANGE. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11041001 ↗
• MalfunctionFeb 14, 2019Difficult to Fold, Unfold or Collapse; Obstruction of Flow; Difficult to Fold, Unfold or Collapse; Obstruction of Flow

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA FLEXTEND TTS PEDIATRIC V NECK FLANGE TRACHEOSTOMY TUBE CUFF "WOULD NOT UNFOLD ON ONE SIDE OF THE CANNULA". IT WAS ALSO REPORTED THAT "THE BOND DISSOLVED AS MORE PRESSURE AND MORE WATER WAS APPLIED AS THE "CANNULA WAS BLOCKED WITH WATER". NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8340204 ↗
• MalfunctionMay 16, 2018Inflation Problem; Leak/Splash; Decrease in Pressure; Inflation Problem; Leak/Splash; Decrease in Pressure

  USER FACILITY REPORTED THAT A TRACHEOSTOMY TUBE CUFF LEAKED AFTER THE TUBE HAD BEEN IN SITU FOR 7 DAYS. THE CANNULA HAD BEEN PREVIOUSLY CLEANED WITH TRACOE CLEANING POWDER. NO PATIENT OR CLINICAL INJURY WERE ASSOCIATED WITH THIS INCIDENT. AFTER THE TRACHEOSTOMY TUBE WAS REMOVED, THE CUFF LEAK WAS VISUALLY CONFIRMED BY FILLING THE CUFF INFLATION LINE WITH WATER AND OBSERVING THE LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520318 ↗
• MalfunctionMay 16, 2018Inflation Problem; Leak/Splash; Decrease in Pressure; Scratched Material; Inflation Problem; Leak/Splash; Decrease in Pressure; Scratched Material

  USER FACILITY REPORTED THAT A TRACHEOSTOMY TUBE CUFF LEAKED AND BLOCKING OCCURRED AFTER THE TUBE HAD BEEN IN SITU FOR 10 DAYS. THE CANNULA HAD BEEN PREVIOUSLY CLEANED WITH TRACOE CLEANING POWDER. NO PATIENT OR CLINICAL INJURY WERE ASSOCIATED WITH THIS INCIDENT. AFTER THE TRACHEOSTOMY TUBE WAS REMOVED, THE CUFF LEAK WAS VISUALLY CONFIRMED BY FILLING THE CUFF INFLATION LINE WITH WATER AND OBSERVING THE FLUID LEAK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7520317 ↗

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.