Bivona 67PFS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 10351688518620), received between Feb 13, 2019 and Jul 1, 2026 — classified as 7 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (16 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-2613-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF DID NOT INFLATE UNIFORMLY AT FIRST BUT INFLATED AFTER 8 ML OF AIR WAS ADDED. AFTER INSERTION, THE CUFF DEFLATED DURING THERAPY, CAUSING THE MECHANICAL VENTILATOR TO ALARM DUE TO A CUFF LEAK. THE CAREGIVER REINFLATED THE CUFF, BUT IT DEFLATED AGAIN LATER THE SAME DAY, SO THE TRACHEOSTOMY TUBE WAS REPLACED. THERE WAS A PATIENT INVOLVEMENT AND THERE WERE NO ADDITIONAL ADVERSE CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25681400 ↗
• MalfunctionJun 29, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF DID NOT INFLATE UNIFORMLY AND SUBSEQUENTLY DEFLATED DURING THERAPY, RESULTING IN VENTILATOR ALARMS DUE TO A CUFF LEAK. THE CUFF WAS REINFLATED, BUT THE ISSUE RECURRED THE SAME DAY, REQUIRING REPLACEMENT OF THE TRACHEOSTOMY TUBE. THERE WAS PATIENT INVOLVEMENT WITH NO HARM, THE CUFF MALFUNCTION COULD COMPROMISE VENTILATION AND POTENTIALLY AFFECT THE PATIENT IF IT WERE TO RECUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25654592 ↗
• MalfunctionNov 3, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF WAS NOT FULLY DEFLATED, ONLY ONE SIDE WAS INFLATED, AND THE PATIENT WAS HARMED DUE TO AIR LEAKAGE AROUND THE TRACHEA. PER REPORTER, THE PEDIATRIC PATIENT'S OUTCOME WAS STILL ONGOING.

  Patient problems: Insufficient Information

  MAUDE report 23457619 ↗
• MalfunctionDec 3, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS DEFECTIVE AND DID NOT COMPLETELY ENCIRCLE THE TUBE/STUCK TO ONE SIDE OF THE TUBE. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT USE. THE EVENT OCCURRED DURING TESTING OF THE CUFF. THERE WAS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833694 ↗
• InjuryOct 21, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON AT THE END DID NOT PROPERLY INFLATE. IT WAS ONLY A PARTIAL INFLATION OF THE BALLOON. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20499780 ↗
• InjuryJun 26, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT FELT THEIR TRACHEOSTOMY WAS BLOCKED. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS DONE AND UPON INSERTION, THE PATIENT NOTED THEY WERE UNCOMFORTABLE WITH INCREASED WORK OF BREATHING. A SECOND TRACH CHANGE WAS DONE WHICH RESOLVED THE ISSUE. ON INSPECTION, IT WAS NOTED THAT THE CUFF HAD INFLATED ASYMMETRICALLY. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(4) .BOTH REPRESENT THE SAME PATIENT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 17198218 ↗
• InjuryJun 22, 2023Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT THE PATIENT FELT THEIR TRACHEOSTOMY WAS BLOCKED. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS DONE AND UPON INSERTION, THE PATIENT NOTED THEY WERE UNCOMFORTABLE WITH INCREASED WORK OF BREATHING. A SECOND TRACH CHANGE WAS DONE WHICH RESOLVED THE ISSUE. ON INSPECTION, IT WAS NOTED THAT THE CUFF HAD INFLATED ASYMMETRICALLY.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 17187151 ↗
• MalfunctionMar 28, 2023Filling Problem; Filling Problem

  IT WAS REPORTED THAT DURING THE TESTING, THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16632755 ↗
• MalfunctionFeb 23, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WOULD NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16432942 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WOULD NOT INFLATE DESPITE PILOT BEING FILLED. FOUND DURING PRE-TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061889 ↗
• MalfunctionOct 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT TWO TRACHEOSTOMY TUBES WERE FOUND TO BE DAMAGED IN DIFFERENT LOCATIONS. THE DAMAGE THAT WAS FOUND WAS TO THE CUFF. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668502 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15468852 ↗
• MalfunctionSep 22, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THREE TIMES THE CUFF HASN'T BEEN INFLATING CORRECTLY. THE CUFF STICKS ON ONE SIDE DESPITE ADDING MORE STERILE WATER. THIS LEADS TO CONSTANT ISSUES WITH A LARGE AIR LEAK AND NOT GETTING PROPER VOLUMES CREATING WORK OF BREATHING DIFFICULTIES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463736 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE DEVICE IS NOT INFLATING PROPERLY DESPITE CUFF MANIPULATION. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446805 ↗
• MalfunctionSep 14, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED TWO TRACH TUBES, BOTH OF WHICH WOULD NOT HOLD AIR. OCCURRED PRIOR TO PATIENT USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15417530 ↗
• MalfunctionSep 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WERE WHITE AND BROWN STAINS ON THE CUFF AFTER STERILIZATION. BEFORE STERILIZATION, THE TUBE WAS WASHED WITH MILD SOAP AND WATER. THE TUBE WAS UNUSABLE AND ANOTHER ONE WAS USED. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15414726 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PATIENT RECEIVED TWO TRACH TUBES, BOTH OF WHICH WOULD NOT HOLD AIR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410903 ↗
• MalfunctionSep 7, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT A CUSTOMER RECEIVED A DEFECTIVE TRACH TUBE FROM THE DISTRIBUTOR. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15371639 ↗
• InjuryJun 24, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CHILD HAD A HISTORY OF ONDINE'S SYNDROME AND WAS VENTILATED DURING SLEEP VIA A TRACHEOSTOMY TUBE. THE PATIENT WAS ADMITTED TO THE DEPARTMENT FOR A RE-EVALUATION. AT 8:30 IN THE MORNING, THE PROFESSIONALS HEARD THE VENTILATOR ALARM AND OBSERVED THAT THE VENTILATOR WAS DISCONNECTED FROM THE TRACHEOSTOMY TUBE. THE CHILD WAS NON REACTIVE WITH BLUE LIPS, HEART RATE 37 AND 7 PERCENT OXYGEN SATURATION (SPO2). RESUSCITATION WAS INITIATED. VENTILATION WAS PERFORMED WITH A ONE-WAY VALVE SELF-FILLING BALLOON UNTIL HELP ARRIVED. THE CANNULA WAS BLOCKED AND SUCTION WAS NOT POSSIBLE. THE CANNULA WAS CHANGED AND RECOVERY OF 100 PERCENT SPO2 AND 80 CF OCCURRED QUICKLY WITH SOME INSUFFLATIONS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S STATUS WAS RECOVERED. THE INSTITUTION ANALYZED THE SITUATION AND FOUND THAT THE MAIN CONTRIBUTING FACTOR WAS THE LACK OF REPORTING OF ALARMS FROM THE PATIENT'S VENTILATOR, WHICH DID NOT ALLOW FOR RAPID IDENTIFICATION OF THE INCIDENT.

  Patient problems: Airway Obstruction; Bradycardia; Cyanosis; Hypoxia

  MAUDE report 14798746 ↗
• InjuryJun 15, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE CHILD HAD A HISTORY OF ONDINE'S SYNDROME AND WAS VENTILATED DURING SLEEP VIA A TRACHEOSTOMY TUBE. THE PATIENT WAS ADMITTED TO THE DEPARTMENT FOR A RE-EVALUATION. AT 8:30 IN THE MORNING, THE PROFESSIONALS HEARD THE VENTILATOR ALARM AND OBSERVED THAT THE VENTILATOR WAS DISCONNECTED FROM THE TRACHEOSTOMY TUBE. THE CHILD WAS NON REACTIVE WITH BLUE LIPS, HEART RATE 37 AND 7 PERCENT OXYGEN SATURATION (SPO2). RESUSCITATION WAS INITIATED. VENTILATION WAS PERFORMED WITH A ONE-WAY VALVE SELF-FILLING BALLOON UNTIL HELP ARRIVED. THE CANNULA WAS BLOCKED AND SUCTION WAS NOT POSSIBLE. THE CANNULA WAS CHANGED AND RECOVERY OF 100 PERCENT SPO2 AND 80 CF OCCURRED QUICKLY WITH SOME INSUFFLATIONS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT'S STATUS WAS RECOVERED. THE INSTITUTION ANALYZED THE SITUATION AND FOUND THAT THE MAIN CONTRIBUTING FACTOR WAS THE LACK OF REPORTING OF ALARMS FROM THE PATIENT'S VENTILATOR, WHICH DID NOT ALLOW FOR RAPID IDENTIFICATION OF THE INCIDENT.

  Patient problems: Airway Obstruction; Bradycardia; Cyanosis; Hypoxia

  MAUDE report 14699385 ↗
• MalfunctionJun 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUFF WOULD NOT INFLATE. NO PATIENT INVOLVEMENT, DISCOVERED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631150 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON OPENING OF THE DEVICE, ONLY ONE SIDE OF THE CUFF WAS INFLATING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13484757 ↗
• MalfunctionFeb 8, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON OPENING OF THE DEVICE, ONLY ONE SIDE OF THE CUFF WAS INFLATING. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13481012 ↗
• MalfunctionApr 30, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON A SMITHS MEDICAL TRACH TUBE HASN'T BEEN INFLATING CORRECTLY. THE CUFF STICKS ON ONE SIDE DESPITE ADDING MORE STERILE WATER. THIS LEADS TO CONSTANT ISSUES WITH A LARGE AIR LEAK AND NOT GETTING PROPER VOLUMES CREATING WORK OF BREATHING DIFFICULTIES. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11758497 ↗
• MalfunctionApr 14, 2021Inflation Problem; Gas/Air Leak; Inflation Problem; Gas/Air Leak

  IT WAS REPORTED THAT THE CUFF ON THE BIVONA TRACHEOSTOMY TUBE WAS NOT INFLATING CORRECTLY. THE CUFF WAS STICKING TO ONE SIDE EVEN AFTER MORE STERILE WATER WAS ADDED. THIS ISSUE WAS LEADING TO A LARGE AIR LEAK THAT WAS IN TURN CREATING WORK OF BREATHING DIFFICULTIES. NO PATIENT INJURY OR FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT YET BEEN RECEIVED. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 11665298 ↗

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.