Bivona 67P045Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15021312006285), received between Aug 1, 2017 and Jul 7, 2026 — classified as 4 deaths, 3 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (11 reports).

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

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-2610-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 7, 2026Gas/Air Leak

  IT WAS REPORTED THAT AFTER INFLATING THE BALLOON, THE CLINICIAN RETURNED TO THE PATIENT AND FOUND THAT THE TRACHEOSTOMY TUBE BALLOON HAD DETACHED AND WAS MISSING. THERE WAS PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25739320 ↗
• InjuryDec 11, 2025Disconnection; Disconnection

  IT WAS REPORTED THAT THEY EXPERIENCED A FAILED TRACH WHERE THE TRACH FELL OUT OF THE PATIENT. THE EVENT OCCURRED WHILE IN USE WITH PATIENT. THERE WAS MEDICAL INTERVENTION REQUIRED, THE TRACH WAS REPLACED WITH A NEW TRACH. THERE WERE PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23779262 ↗
• MalfunctionApr 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRODUCT DIDN'T INFLATE PROPERLY - INFLATES LOPSIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19215276 ↗
• MalfunctionApr 30, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PRODUCT DIDN'T INFLATE PROPERLY - INFLATES LOPSIDED. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19212576 ↗
• MalfunctionOct 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THREE CUFFS WERE UNABLE TO INFLATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15597598 ↗
• MalfunctionSep 26, 2022Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THE DEVICE HAD A DEFECTIVE BALLOON. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15486191 ↗
• InjuryJul 27, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH THE TRACHEOSTOMY TUBES ON ONE OF THEIR PEDIATRIC PATIENTS. THE PATIENT DID HAVE AN ISSUE WITH DESATURATION AND THEIR TRACHEOSTOMY TUBE NEEDED TO BE CHANGED OUT. ADDITIONAL INFORMATION RECEIVED VIA CUSTOMER RESPONSE EMAIL DATED 01-JUL-2022: THE CUFF DID NOT SEAL WITH PLACEMENT OF STERILE WATER, LARGE LEAK NOTED, DECOMPENSATION. NURSE WAS CALLED TO BEDSIDE, COULD HEAR INFANT CRYING WITH DECOMPENSATION, ADDED 1 CC OF STERILE WATER AND THERE WAS NO EFFECT, CHANGED OUT TO ANOTHER SIZE TRACHEOTOMY TUBE. PREMATURELY NEEDED TO CHANGE TRACHEOSTOMY TUBE UNTIL WE HAD A GOOD SEAL WITH CUFF AND NO LEAK AND NO DECOMPENSATION, GOOD BILATERAL BREATH SOUNDS.

  Patient problems: Decreased Respiratory Rate; Low Oxygen Saturation

  MAUDE report 15117197 ↗
• MalfunctionJul 7, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHILE PREPARING TO DO A ROUTINE TRACHEOSTOMY TUBE CHANGE, THE BALLOON WAS NOT INFLATING FULLY WHEN CHECKED PRIOR TO TUBE CHANGE. THERE WERE NO VISIBLE SIGNS OF TEARS OR LEAKS WHEN BALLOON WAS INFLATED BUT "IT DIDN'T LOOK RIGHT". TWO TRACHS WERE OBSERVED TO HAVE THIS ISSUE FROM THE SAME LOT NUMBER. A THIRD TRACH WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14945106 ↗
• MalfunctionJul 7, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHILE PREPARING TO DO A ROUTINE TRACHEOSTOMY TUBE CHANGE, THE BALLOON WAS NOT INFLATING FULLY WHEN CHECKED PRIOR TO TUBE CHANGE. THERE WERE NO VISIBLE SIGNS OF TEARS OR LEAKS WHEN BALLOON WAS INFLATED BUT "IT DIDN'T LOOK RIGHT". TWO TRACHS WERE OBSERVED TO HAVE THIS ISSUE FROM THE SAME LOT NUMBER. A THIRD TRACH WAS USED WITHOUT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14944432 ↗
• MalfunctionAug 7, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE BALLOON TO A SMITHS MEDICAL PORTEX® BIVONA® TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS FOUND TO BE ASYMMETRICAL DURING PRE-USE CHECK. THE BALLOON WAS NOTED NOT TO INFLATE ON BOTH SIDES OF THE TUBE. THERE WERE NO REPORTED ADVERSE HEALTH EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759103 ↗
• MalfunctionFeb 14, 2018Break; Break

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE DOES NOT WORK. THERE WAS NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7270243 ↗
• InjurySep 13, 2017Inflation Problem; Material Rupture; Inflation Problem; Material Rupture

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® PEDIATRIC TTS¿ TRACHEOSTOMY TUBE DIDN'T REMAIN INFLATED. THE DEFLATION OCCURRED AFTER 20 DAYS IN USE. THE TRACHEOSTOMY TUBE WAS CHANGED NINE DAYS EARLY, IMMEDIATELY AFTER NOTICING THE CUFF WAS DEFLATED. THE PATIENT WAS MONITORED BY NURSES BECAUSE OF A "RISK FOR INHALATION". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6862323 ↗
• DeathAug 1, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY. THE CUFF WOULD ONLY EXPAND ON ONE SIDE OF THE SHAFT, AND WOULD DEFLATE AFTER BEING INSERTED. THE PATIENT HAD A RESPIRATORY EVENT, POSSIBLY DUE TO THE FAILURE WITH THE TRACHEOSTOMY TUBE HAD A RESUSCITATION BAG APPLIED AND WAS TRANSPORTED TO THE HOSPITAL, WHERE THE PATIENT WAS ADMITTED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS.

  Patient problems: Death

  MAUDE report 6757983 ↗
• DeathAug 1, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY. THE CUFF WOULD ONLY EXPAND ON ONE SIDE OF THE SHAFT, AND WOULD DEFLATE AFTER BEING INSERTED. THE PATIENT HAD A RESPIRATORY EVENT, POSSIBLY DUE TO THE FAILURE WITH THE TRACHEOSTOMY TUBE HAD A RESUSCITATION BAG APPLIED AND WAS TRANSPORTED TO THE HOSPITAL, WHERE THE PATIENT WAS ADMITTED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS.

  Patient problems: Death

  MAUDE report 6757971 ↗
• DeathAug 1, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY. THE CUFF WOULD ONLY EXPAND ON ONE SIDE OF THE SHAFT, AND WOULD DEFLATE AFTER BEING INSERTED. THE PATIENT HAD A RESPIRATORY EVENT, POSSIBLY DUE TO THE FAILURE WITH THE TRACHEOSTOMY TUBE HAD A RESUSCITATION BAG APPLIED AND WAS TRANSPORTED TO THE HOSPITAL, WHERE THE PATIENT WAS ADMITTED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS.

  Patient problems: Death

  MAUDE report 6757967 ↗
• DeathAug 1, 2017Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY. THE CUFF WOULD ONLY EXPAND ON ONE SIDE OF THE SHAFT, AND WOULD DEFLATE AFTER BEING INSERTED. THE PATIENT HAD A RESPIRATORY EVENT, POSSIBLY DUE TO THE FAILURE WITH THE TRACHEOSTOMY TUBE HAD A RESUSCITATION BAG APPLIED AND WAS TRANSPORTED TO THE HOSPITAL, WHERE THE PATIENT WAS ADMITTED. IT WAS LATER REPORTED THAT THE PATIENT EXPIRED DUE TO COMPLICATIONS.

  Patient problems: Death

  MAUDE report 6757935 ↗