Bivona 67P050Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 15021312006292), received between Feb 2, 2018 and Mar 17, 2026 — classified as 5 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (19 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. 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-2610-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2026Failure to Deliver

  IT WAS REPORTED THAT THEY PICKED UP A TRACH FROM A PATIENT THAT DID NOT INFLATE ALL THE WAY. ONLY ONE SIDE OF IT WOULD INFLATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND THERE WAS UNKNOWN PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24617492 ↗
• InjuryMay 13, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFED TUBE FAILED TO INFLATE. THE EVENT WAS DISCOVERED DURING POST TUBE INSERTION IN THE HOSPITAL WITH PATIENT INVOLVEMENT. THEY HAD TO REMOVE THE TUBE AND INSERT A NEW ONE. THE EVENT WAS RESOLVED WITH THE NEW TUBE INSERTION. THE CUFF WAS INFLATED WITH 4 MLS WATER FOR INJECTION. WHEN THE TUBE WAS REPLACED WITH A WORKING TUBE WITH THE SAME SIZE AND STYLE TRACHEOSTOMY THE 4 ML CUFF INFLATION ALLOWED THE INTERNAL CUFF TO INFLATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299145 ↗
• MalfunctionJan 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOONS WERE MALFUNCTIONING. NEITHER BALLOON WOULD FULLY INFLATE. BOTH UNITS WERE DISCOVERED PRIOR TO PATIENT USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE SECOND PRODUCT FAULT WAS DOCUMENTED ON CN-253675.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546163 ↗
• MalfunctionJan 19, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOONS WERE MALFUNCTIONING. NEITHER BALLOON WOULD FULLY INFLATE. BOTH UNITS WERE DISCOVERED PRIOR TO PATIENT USE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE SECOND PRODUCT FAULT WAS DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546015 ↗
• MalfunctionNov 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE ITEM DID NOT INFLATE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18231988 ↗
• MalfunctionMay 10, 2023Inflation Problem; Inflation Problem

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16906505 ↗
• MalfunctionFeb 10, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED DURING PRE TEST, CUFF WAS NOT INFLATING. PILOT BALLOON WAS INFLATING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16354423 ↗
• MalfunctionSep 22, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PRE-TEST, THE TRACHEOSTOMY TUBE CUFF WAS IN A BLOCKED AND NOT ROUND STATE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15463051 ↗
• MalfunctionSep 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF WAS NOT UNIFORM WITH TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460054 ↗
• MalfunctionSep 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF WAS NOT UNIFORM WITH TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460053 ↗
• MalfunctionSep 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF WAS NOT UNIFORM WITH TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460051 ↗
• MalfunctionSep 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF WAS NOT UNIFORM WITH TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460044 ↗
• MalfunctionSep 20, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF WAS NOT UNIFORM WITH TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460042 ↗
• MalfunctionSep 20, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT DURING PRE-TEST OF THE TRACHEOSTOMY TUBE CUFF, ONLY HALF OF THE CUFF INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456260 ↗
• MalfunctionSep 16, 2022Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  IT WAS REPORTED THAT THE CUFF IS NOT UNIFORM WITH SIX TRACHEOSTOMY TUBES. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436669 ↗
• MalfunctionSep 15, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT THE CUFF IS INFLATING ASYMMETRICALLY DURING PRE-CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426965 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF IS INFLATING ASYMMETRICALLY DURING PRE-CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426924 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF IS INFLATING ASYMMETRICALLY DURING PRE-CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426901 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF IS INFLATING ASYMMETRICALLY DURING PRE-CHECK. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15426855 ↗
• MalfunctionSep 13, 2022Short Fill; Short Fill

  IT WAS REPORTED THAT THE DEVICE WOULD ONLY INFLATE HALFWAY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410142 ↗
• MalfunctionApr 11, 2022Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT DURING THE CUFF INFLATION TEST, BEFORE PATIENT PLACEMENT: THE CUFF DID NOT INFLATE. NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14073478 ↗
• MalfunctionFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON IS NOT INFLATING CIRCUMFERENTIALLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13500098 ↗
• MalfunctionFeb 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON IS NOT INFLATING CIRCUMFERENTIALLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13499944 ↗
• MalfunctionJan 7, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THE CUFF DID NOT INFLATE PROPERLY. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13195890 ↗
• MalfunctionDec 22, 2021Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT HOLDING WATER SO A TRACH CHANGE HAD TO BE DONE. THE CUFF HAD A SMALL HOLE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13066488 ↗