Bivona 67N030Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15021312006216), received between Jan 8, 2019 and Mar 26, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (10 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-2606-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DOES NOT FULLY INFLATE. THE TRACH WAS BEING CHECKED PRIOR TO INSERTION WITH STERILE WATER. EVEN AFTER MASSAGING THE CUFF, IT WOULD STILL NOT INFLATE FULLY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18980598 ↗
• MalfunctionJan 18, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THREE CUFFS WERE NOT INFLATING. A FOURTH TRACH WAS ABLE TO INFLATE AFTER MANUAL MANIPULATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16200230 ↗
• MalfunctionJan 6, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT, DURING PRE-TEST, THREE CUFFS WERE NOT INFLATING. A FOURTH TRACH WAS ABLE TO INFLATE AFTER MANUAL MANIPULATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118853 ↗
• MalfunctionJan 6, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT, DURING PRE-TEST, THREE CUFFS WERE NOT INFLATING. A FOURTH TRACH WAS ABLE TO INFLATE AFTER MANUAL MANIPULATION. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16118838 ↗
• MalfunctionSep 14, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING CORRECTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418177 ↗
• MalfunctionSep 14, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING CORRECTLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418173 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST THE CUFF WOULD NOT INFLATE. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410056 ↗
• MalfunctionOct 15, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE THAT WILL NOT HOLD INFLATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12642254 ↗
• MalfunctionMay 14, 2020Deflation Problem; Inflation Problem

  PATIENT WAS DUE FOR A TRACHEOSTOMY TUBE CHANGE BY EARS/NOSE/THROAT (ENT) DOCTOR. THE FELLOW TESTED THE CUFF AND THE BALLOON DID NOT DEFLATE. TWO TRACHEOSTOMY TUBES WERE TESTED AND DID NOT INFLATE, THE THIRD TRACH BALLOON INFLATED. THIS WAS A PLANNED SITUATION AND THE TRACH TUBE WAS NOT CHANGED UNTIL THERE WAS A TRACH TUBE THAT HAD A BALLOON THAT INFLATED. THE TRACH TUBES WERE BOTH: NEONATAL BIVONA TTS 3.0.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10055611 ↗
• MalfunctionNov 7, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA NEONATAL TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE HAD A "FAULTY BALLOON". NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 9292538 ↗
• MalfunctionMay 17, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED NEONATAL WITH V NECK FLANGE TRACHEOSTOMY TUBE PILOT BALLOON INFLATED, BUT THE CUFF DID NOT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8620894 ↗
• MalfunctionMay 17, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS CUFFED NEONATAL WITH V NECK FLANGE TRACHEOSTOMY TUBE PILOT BALLOON INFLATED, BUT THE CUFF DID NOT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8620892 ↗
• MalfunctionJan 8, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA NEONATAL TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE CUFF DOES NOT INFLATE AT ALL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8227719 ↗