Bivona 67SP055Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15021312000757), received between Dec 9, 2018 and Dec 8, 2025 — classified as 5 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (7 reports).

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

5 other recalls cover devices cleared under the same FDA submission (K083641, K914088); 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-2615-2024 · Root cause: Under Investigation by firm · Recall details · 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.

• MalfunctionDec 8, 2025Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT THE BALLON WOULD NOT INFLATE AND ALSO STUCK ON THE SHAFT. THE EVENT OCCURRED UPON OPENING AT PATIENT'S HOME. THE OUTCOME OF THE EVENT WAS ON GOING AND AWAITING FOR REPLACEMENT. THE CHILD WAS VENT DEPENDENT AND GOT THE SAME RESULT WITH THIS TRACH AS THE PREVIOUS ONE WHICH WAS REGISTERED UNDER (B)(4) BUT STOPPED BEFORE INSTILLING MORE AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23745619 ↗
• MalfunctionOct 31, 2023Complete Blockage; Inflation Problem; Complete Blockage; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE DID NOT INFLATE DURING TESTING. THERE WAS A BLOCKAGE BETWEEN THE OUTSIDE BALLOON AND THE INSIDE CUFF PREVENTING THE INFLATION ON THE INSIDE CUFF. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18042987 ↗
• MalfunctionFeb 14, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE TRACH TUBE WAS DEFECTIVE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16371746 ↗
• MalfunctionFeb 13, 2023Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THAT THE TRACH TUBE WAS DEFECTIVE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16362999 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS BEING TESTED WITH STERILE WATER IN CUFF PRIOR TO INSERTION AND ONLY ONE SIDE OF THE CUFF INFLATED. SURGEON PRESENT AT THE TIME AS WELL AND WITNESSED DEFECTIVE CUFF. CUFF WAS MANIPULATED, BUT THE OTHER SIDE STILL DID NOT OPEN UP. A NEW CUFF TRACH WAS OBTAINED WHICH WORKED WELL. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446697 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446525 ↗
• MalfunctionSep 19, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT EVENLY INFLATING. CUFF STICKING TO THE PLASTIC MOLDED CONTAINER. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446447 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427175 ↗
• MalfunctionAug 23, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUFF WAS STICKING TO THE SHAFT OF THE DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280307 ↗
• MalfunctionAug 23, 2022Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE CUFF WAS STICKING TO THE SHAFT OF THE DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280289 ↗
• MalfunctionAug 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST OF A ROUTINE TRACH CHANGE, TWO CUFFS INFLATED ASYMMETRICALLY. A THIRD TRACH WAS USED TO COMPLETED THE TRACH CHANGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277446 ↗
• InjurySep 23, 2019Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS OBSERVED TO BE DEFLATING. THE DEFECTIVE TRACH TUBES WERE REPORTED TO BE BROUGHT IN BY THE RESPIRATORY THERAPIST; INDICATING THEY HAD BEEN REMOVED. THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9106919 ↗
• InjuryJul 2, 2019Break; Break

  IT WAS REPORTED THAT PRIOR TO A ROUTINE TRACHEOSTOMY TUBE CHANGE OUT, THE CUFF HAD BURST, CAUSING THE PATIENT TO LOSE VENTILATION. THE PATIENT WAS TAKEN TO A HOSPITAL FOR A TUBE CHANGE OUT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8755896 ↗
• InjuryDec 9, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE CUFF LEAKED IMMEDIATELY UPON USE. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) CHANGE OUT WAS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145356 ↗
• InjuryDec 9, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE CUFF LEAKED IMMEDIATELY UPON USE. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) CHANGE OUT WAS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145353 ↗
• InjuryDec 9, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA TTS (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE CUFF LEAKED IMMEDIATELY UPON USE. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) CHANGE OUT WAS REQUIRED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8145350 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K914088. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0930-05 · Apr 26, 2005 · Terminated
  Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
• Z-0302-06 · Feb 17, 2005 · Terminated
  Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.