Bivona 67PFS55Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10351688518651), received between Apr 14, 2020 and Jul 30, 2026 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2026Gas/Air Leak

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50086786 ↗
• MalfunctionJan 13, 2025Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT AN EMERGENCY TUBE CHANGE OCCURRED BECAUSE THE WATER CUFF WOULD FULLY INFLATE, BUT ONCE PLACED ON THE CHILD, IT WOULD GRADUALLY LEAK AROUND THE CUFF PART. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139656 ↗
• MalfunctionJan 5, 2024Break; Separation Problem; Unintended Deflation; Break; Separation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE PORT TO INFLATE THE BALLOON BROKE OFF AND THE BALLOON DEFLATED. "THE STOMA WAS NOT SEALED AND LEAKED". ADVERSE PATIENT EFFECTS ARE UNKNOWN.

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

  MAUDE report 18458090 ↗
• MalfunctionDec 13, 2023Failure to Unfold or Unwrap; Failure to Unfold or Unwrap

  IT WAS REPORTED THAT THE "CLIENT REQUESTED AN INVESTIGATION FOR THE THE BIVONA TTS FLEXTEND 5.5 PRODUCT AND A CORRECTION OF THE INVOICE". ACCORDING TO THE CUSTOMER THE CUFF IS TOO TIGHTLY CONNECTED TO THE CANNULA. IT CANNOT BE UNFOLDED. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18321028 ↗
• MalfunctionNov 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS TOO TIGHTLY CONNECTED TO THE CANNULA AND COULD NOT BE "DEPLOYED". PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18107179 ↗
• MalfunctionDec 31, 2020Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND WAS LEAKING WITH ADDITIONAL INFORMATION RECEIVED EVENT REQUIRED TRACH CHANGE OUT WITH NO ADVERSE EVENTS REPORTED. UNKNOWN IF TRACHEOSTOMY WAS NEW OR LONG TERM USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11101170 ↗
• MalfunctionDec 4, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem

  CUFF WAS MOLDY AFTER BEING USE FOR TWO WEEKS. BLACK MOLDING WAS ABLE TO BE SEEN INSIDE THE CUFF AND AROUND THE BASE OF THE PILOT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10946871 ↗
• MalfunctionJul 20, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS TRACHEOSTOMY TUBE WAS FOUND TO BE LEAKING FOUR WEEKS AFTER PLACEMENT. IT WAS REPORTED THAT 2MLS OF WATER WERE MISSING. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10297856 ↗
• InjuryApr 14, 2020Leak/Splash; Mechanical Problem; No Apparent Adverse Event; Leak/Splash; Mechanical Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION ON COMPLAINT OF TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND LEAKING CAUSING PATIENT SECREATIONS AND DIFFICULTY BREATHING. SUMMARY IN H 10.

  Patient problems: Airway Obstruction; Hypoxia; Respiratory Distress

  MAUDE report 9960354 ↗
• MalfunctionApr 14, 2020Leak/Splash; Mechanical Problem; No Apparent Adverse Event; Leak/Splash; Mechanical Problem; No Apparent Adverse Event

  ADDITIONAL INFORMATION ON COMPLAINT OF TRACHEOSTOMY SILICONE -BIVONA NEO/PED FLEXTEND LEAKING CAUSING PATIENT SECRETIONS AND DIFFICULTY BREATHING. SUMMARY IN H-10.

  Patient problems: Airway Obstruction; Hypoxia; Respiratory Distress

  MAUDE report 9960352 ↗

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.