Bivona 67PFS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10351688518637), received between Oct 9, 2018 and Dec 3, 2024 — classified as 4 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (15 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• 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 20833368 ↗
• 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 20833366 ↗
• MalfunctionApr 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE INFLATING UNEVENLY AND WILL CREATE UNEVEN PRESSURE ON THE TRACHEA. THE ISSUE WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19100460 ↗
• MalfunctionApr 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE INFLATING UNEVENLY AND WILL CREATE UNEVEN PRESSURE ON THE TRACHEA. THE ISSUE WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095928 ↗
• MalfunctionApr 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE INFLATING UNEVENLY AND WILL CREATE UNEVEN PRESSURE ON THE TRACHEA. THE ISSUE WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095830 ↗
• MalfunctionApr 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE INFLATING UNEVENLY AND WILL CREATE UNEVEN PRESSURE ON THE TRACHEA. THE ISSUE WAS DISCOVERED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM. NO MEDICAL INTERVENTION REQUIRED. OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19095633 ↗
• MalfunctionAug 22, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT ABLE TO BE BLOCKED. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17596586 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CHILD HAD TRACH PLACED ON (B)(6) 2023 AND DURING THE NIGHT THE CHILD BIT INTO THE BALLOON. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17302241 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CHILD HAD TRACH PLACED ON (B)(6) 2023 AND DURING THE NIGHT THE CHILD BIT INTO THE BALLOON. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17302225 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CHILD HAD TRACH PLACED ON (B)(4) 2023 AND DURING THE NIGHT THE CHILD BIT INTO THE BALLOON. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17302065 ↗
• MalfunctionJul 11, 2023Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT THE CHILD HAD TRACH PLACED ON (B)(6) 2023 AND DURING THE NIGHT THE CHILD BIT INTO THE BALLOON. ADVERSE PATIENT EFFECTS ARE UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17302009 ↗
• InjuryDec 29, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY BALLOON ONLY INFLATING HALFWAY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER WITH NO HARM TO THE PATIENT. CLINICAL TEAM HAS NOT REPORTED ANY FURTHER MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067569 ↗
• MalfunctionOct 25, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THREE BALLOONS WERE UNEQUALLY INFLATING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15668353 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS OF TWO TRACHS ARE NOT INFLATING SYMMETRICALLY AND ONLY INFLATES ON ONE SIDE. THE CUFFS WERE MASSAGED AND INFLATION WAS ATTEMPTED AGAIN WITH NO RESOLUTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176331 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS OF TWO TRACHS ARE NOT INFLATING SYMMETRICALLY AND ONLY INFLATES ON ONE SIDE. THE CUFFS WERE MASSAGED AND INFLATION WAS ATTEMPTED AGAIN WITH NO RESOLUTION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13176114 ↗
• MalfunctionJan 6, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE PILOT BALLOON IS INFLATING BUT THE CUFF IS NOT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13175908 ↗
• MalfunctionOct 26, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT TRACH BASE FELL OFF A SMITHS MEDICAL TRACH TUBE DUE TO THE PATIENT PULLING ON THE VENT AIRWAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12700874 ↗
• MalfunctionJun 5, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT THE CUFF ON A SMITHS MEDICAL (B)(4) FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS SUSPECTED TO BE LEAKING AS IT HAD TO BE BLOCKED FREQUENTLY. NO REPORTED MEDICAL INTERVENTION. NO PATIENT ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8672796 ↗
• MalfunctionFeb 11, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CUFF OF A SMITHS MEDICAL TRACHEOSTOMY WAS NOT INFLATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327938 ↗
• MalfunctionFeb 11, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT THE CUFF OF A SMITHS MEDICAL TRACHEOSTOMY WAS NOT INFLATING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8327867 ↗
• InjuryOct 9, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT, A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE CUFF WOULD ONLY PARTIALLY INFLATE. IT WAS REPORTED THE STAFF WERE ATTEMPTING TO CHANGE OUT AND SIZE UP DURING THIS PEDIATRIC AIRWAY EMERGENCY. TWO MORE TRACH TUBES WERE ATTEMPTED TO BE USED DURING THIS EMERGENCY WITH THE SAME. A DIFFERENT TRACH LOT NUMBER WAS THEN USED AND PLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7948010 ↗
• InjuryOct 9, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT, A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE CUFF WOULD ONLY PARTIALLY INFLATE. IT WAS REPORTED THE STAFF WERE ATTEMPTING TO CHANGE OUT AND SIZE UP DURING THIS PEDIATRIC AIRWAY EMERGENCY. TWO MORE TRACH TUBES WERE ATTEMPTED TO BE USED DURING THIS EMERGENCY WITH THE SAME. A DIFFERENT TRACH LOT NUMBER WAS THEN USED AND PLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947973 ↗
• InjuryOct 9, 2018Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT DURING A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT, A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE CUFF WOULD ONLY PARTIALLY INFLATE. IT WAS REPORTED THE STAFF WERE ATTEMPTING TO CHANGE OUT AND SIZE UP DURING THIS PEDIATRIC AIRWAY EMERGENCY. TWO MORE TRACH TUBES WERE ATTEMPTED TO BE USED DURING THIS EMERGENCY WITH THE SAME. A DIFFERENT TRACH LOT NUMBER WAS THEN USED AND PLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7947925 ↗

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.