Bivona 67NFPS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10351688518798), received between Jul 18, 2017 and Jan 31, 2025 — classified as 9 injuries, 51 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (31 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-2609-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 31, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE PATIENT BROUGHT WITH THEM TO THE CLINIC THREE BROKEN TRACH TUBES. CONDITION OF USE WAS STRAIGHT OUT OF THE BOX, UNUSED, WITH BROKEN TRACH CUFFS- SLIT WHERE THE CUFF MEETS THE SHAFT. THE NEW TRACH REMOVED FROM BOX, INFLATED CUFF WITH STERILE WATER WITH IMMEDIATE LEAKAGE OF WATER FROM CUFF. THE EVENT OCCURRED AT PATIENT'S HOME. THERE WERE NO PATIENT HARM OR ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21283989 ↗
• MalfunctionJan 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONE TRACH TUBE WOULD ONLY INFLATE HALFWAY, AND A SECOND ONE THE CUFF WOULDN'T INFLATE AT ALL. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147539 ↗
• MalfunctionNov 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE. PILOT BALLOON WAS FILLING, BUT NO INFLATION ON CUFF SEEN AT ALL. ADDITIONAL 2 ML WERE INSERTED, PILOT BALLOON OVERFILLED, BUT CUFF WAS STILL NOT INFLATING. THERE WERE NO PATIENT INVOLVEMENT OR HUMAN HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20689244 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT CUFFED TRACHEOSTOMY WAS IN SITU IN A CHILD, EXTERNAL CUFF NOTED TO BE MISSING FROM END OF THE EXTENSION, PREVIOUSLY PRESENT. BREAKAGE OF TUBE, POTENTIAL RESULTING IN AN UNSAFE AIRWAY. TUBE IMMEDIATELY CHANGED. THERE WAS PATIENT INVOLVEMENT. IT WAS STATED THAT THIS WAS AN ISOLATED INCIDENT THAT HAD NO HEALTH CONSEQUENCES OR IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20481595 ↗
• MalfunctionJul 8, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE DEVICE HAD A DEFECTIVE CUFF. THERE WAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19696105 ↗
• MalfunctionJun 7, 2024Contamination; Contamination

  IT WAS REPORTED THAT MULTIPLE TRACHEOSTOMY TUBES ONCE PROCESSED BY CSR ARE BEING RETURNED TO UNIT WITH "FUZZY" SUBSTANCE ON OBTURATOR. THERE IS NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19486058 ↗
• InjuryMay 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT BABY WITH TRACH AND VENT WAS AGITATED, FLAILING ARMS. THE TRACH TUBE HUB DISCONNECTED FROM THE BODY OF THE TRACH TUBE. THEY BELIEVED THAT IT IS A SWIVEL ADAPTER. AN EMERGENCY TRACH TUBE CHANGE WAS PERFORMED, AND THE OUTCOME WAS RESOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19359666 ↗
• MalfunctionApr 23, 2024Defective Device; Insufficient Device Problem Information; Defective Device; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE BALLOON WAS FOUND DEFECTIVE ON PREVIOUSLY STERILIZED TRACH. THE NATURE OF THE "DEFECT" WAS NOT PROVIDED. THE INCIDENT HAPPENED UPON TRACH CHANGED AND DID NOT REACH PATIENT. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19163466 ↗
• MalfunctionNov 22, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON INSPECTION OF NEW TRACH, THE BALLOON FAILED TO INFLATE PRIOR TO INSERTION. TRACH WAS NOT USED ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18195019 ↗
• MalfunctionMar 27, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE HAD AN INVERTED BELL-SHAPED CUFF THAT WOULD NOT INFLATE WELL TOWARDS THE BOTTOM, WITH A MORE ROUNDED TOP. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED, THERE IS A MISSING DIGIT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16621864 ↗
• MalfunctionMar 27, 2023Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE DEVICE WAS REPROCESSED IT HAD A LOPSIDED CUFF; LOOKED "LIKE A BULGE IN A TIRE". THIS CREATED ISSUES WITH THE SEAL AGAINST THE TRACHEAL WALL; CUSTOMER CANNOT EASILY VENTILATE WITH A LEAK. IT IS UNKNOWN IF THIS WAS HOW THE TRACH WAS BEFORE REPROCESSING. THE DEVICE HAD BEEN REPROCESSED LESS THAN 5 TIMES. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED, THERE IS A MISSING DIGIT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16621645 ↗
• MalfunctionMar 27, 2023Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT AFTER THE DEVICE WAS REPROCESSED IT HAD A LOPSIDED CUFF; LOOKED "LIKE A BULGE IN A TIRE". THIS CREATED ISSUES WITH THE SEAL AGAINST THE TRACHEAL WALL; CUSTOMER CANNOT EASILY VENTILATE WITH A LEAK. IT IS UNKNOWN IF THIS WAS HOW THE TRACH WAS BEFORE REPROCESSING. THE DEVICE HAD BEEN REPROCESSED LESS THAN 5 TIMES. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED, THERE IS A MISSING DIGIT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16621588 ↗
• MalfunctionMar 27, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE CUFF WOULD NOT INFLATE AT ALL PRIOR TO USE. THE DEVICE HAD NOT BEEN REPROCESSED. UNFORTUNATELY, THAT PRODUCT WAS THROWN AWAY BY THE PROVIDER. THE REPORTED LOT NUMBER COULD NOT BE VERIFIED, THERE IS A MISSING DIGIT. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16621227 ↗
• MalfunctionMar 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACH TUBE WOULD NOT INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16517981 ↗
• MalfunctionMar 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACH TUBE WOULD NOT INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16513156 ↗
• MalfunctionFeb 21, 2023Device Reprocessing Problem; Gas/Air Leak; Device Reprocessing Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS USED AND REPROCESSED BUT NOW HAS A LOPSIDED APPEARANCE WITH A BULGE, WHICH AFFECTS THE SEAL AGAINST THE TRACHEAL WALL AND MAKES VENTILATION DIFFICULT. THERE HAS BEEN NO REPORT OF PATIENT INJURY, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16414604 ↗
• MalfunctionFeb 21, 2023Device Reprocessing Problem; Device Reprocessing Problem

  IT WAS REPORTED THAT THE TRACH TUBE AFTER RE-PROCESSING HAS AN INVERTED BELL-SHAPED CUFF WITH POOR INFLATION TOWARDS THE BOTTOM AND A MORE ROUNDED TOP. THERE HAS BEEN NO REPORT OF PATIENT INJURY, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16414603 ↗
• MalfunctionFeb 21, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE BEFORE USE (DISCARDED BY THE PROVIDER). THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16414599 ↗
• MalfunctionFeb 21, 2023Device Reprocessing Problem; Gas/Air Leak; Device Reprocessing Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS USED AND REPROCESSED, BUT NOW HAS A LOPSIDED APPEARANCE WITH A BULGE, WHICH AFFECTS THE SEAL AGAINST THE TRACHEAL WALL AND MAKES VENTILATION DIFFICULT. THERE HAS BEEN NO REPORT OF PATIENT INJURY, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16414597 ↗
• MalfunctionFeb 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING FULLY DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16316461 ↗
• InjuryNov 14, 2022Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT WAS DUE FOR WEEKLY TRACH CHANGE. PATIENT HAS A 3.5 TRACH TUBE CUFFED WITH 2ML OF STERILE WATER. AN HOUR AFTER TRACH CHANGE, PATIENT WAS EVENTING WITH INCREASED C02S, RESTRICTED VOLUMES ON VENT AND GIANT AIR LEAK WITH HEAD BOBBING AND RETRACTIONS. RESPIRATORY THERAPIST (RT) AT BEDSIDE WITH REGISTERED NURSE (RN) TROUBLESHOOTING CAUSE OF EVENTS AND INCREASING C02. CHANGED TRACH OUT EMERGENTLY WITH RT; PREVIOUS TRACH CUFF WAS FOUND TO NOT INFLATE. (UNKNOWN LOT NUMBER).

  Patient problems: Hypoventilation; Respiratory Distress Syndrome of Newborns

  MAUDE report 15793632 ↗
• MalfunctionOct 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFFS FAILED TO INFLATE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635773 ↗
• MalfunctionOct 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A HOSPITAL PRE-TEST OF THE TRACH TUBE, THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595620 ↗
• MalfunctionSep 24, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, PATIENT MOTHER WAS TRYING TO INFLATE THE CUFF AND IT DID NOT WORK DESPITE TRYING 4-5 TIMES. SHE THEN TRIED AGAIN AND HEARD A POP AND THE CUFF THEN INFLATED. MOTHER ATTEMPTED TO FILL WITH WATER BUT CUFF LEAKED. SHE OPENED TWO OTHERS AND THE CUFF WOULD NOT INFLATED ON THOSE EITHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15476009 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, PATIENT MOTHER WAS TRYING TO INFLATE THE CUFF AND IT DID NOT WORK DESPITE TRYING 4-5 TIMES. SHE THEN TRIED AGAIN AND HEARD A POP AND THE CUFF THEN INFLATED. MOTHER ATTEMPTED TO FILL WITH WATER BUT CUFF LEAKED. SHE OPENED TWO OTHERS AND THE CUFF WOULD NOT INFLATED ON THOSE EITHER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15467644 ↗

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.