Bivona 67SP035Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 15021312000719), received between Apr 12, 2017 and Aug 22, 2024 — classified as 3 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (9 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 18, 2026.

Recalls naming this device

1. May 29, 2024Class IOpen, 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2024Break; Break

  IT WAS REPORTED THAT BOTH DEVICES BROKE AT THE WING. ONE CANNULA WAS THROWN AWAY, THE OTHER IS AVAILABLE FOR INVESTIGATION. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20039839 ↗
• MalfunctionAug 14, 2024Break; Break

  IT WAS REPORTED THAT THE DEVICE BROKE AT THE WING AFTER BEING INSERTED. THE CHILD WAS NOT INJURED, AS THE TRACHEAL CANNULA WAS REPLACED WITH A NEW ONE WHEN IT WAS DISCOVERED THAT THE WING WAS BROKEN. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19985167 ↗
• MalfunctionJul 11, 2024Contamination; Contamination

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAD A "FUZZY" SUBSTANCE ON OBTURATOR. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19722393 ↗
• InjuryFeb 29, 2024Material Separation; Material Separation

  IT WAS REPORTED THAT A BROKEN "WING" WAS DISCOVERED ON A TRACHEAL CANNULA ON A CHILD. THE TRACHEAL CANNULA WAS CHANGED URGENTLY DURING THE EVENING\NIGHT SHIFT BY THE ENT DEPARTMENT. THE TRACHEAL CANNULA WAS DISCARDED. THE TRACHEAL CANNULA WAS LAST CHANGED ON 27-DEC-2023. THE PARENTS STATED THAT IT WAS ALMOST COMPLETELY OFF. A CRACK AT THE "WING", NEAR THE "CHIMNEY", SAME SIDE AS THE CUFF. THE CUSTOMER REPORTED THAT "THERE IS NO RISK THAT WE DAMAGED THE WING WITH SCISSORS. AFTER THE INCIDENT, THE CIRCUMFERENCE OF THE NECKBAND WAS INCREASED BY 0.5 CM INITIALLY AND THEN BY AN ADDITIONAL 0.5 CM, TOTALING 1 CM, TO REDUCE TENSION ON THE WINGS. THE NECKBAND WAS THEN TIED TIGHTLY SO THAT THE CANNULA CANNOT BE PULLED OUT.¿ RISK OF MAJOR INJURY IF THE WING BROKE, NO FREE AIRWAY. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED. A POSSIBLE LOT NUMBER OF 4348433 WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18808899 ↗
• MalfunctionSep 6, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF COULD NOT BE INFLATED. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691712 ↗
• InjuryJun 20, 2023Inflation Problem; Obstruction of Flow; Inflation Problem; Obstruction of Flow

  IT WAS REPORTED THAT THERE WERE TWO DIFFERENT ISSUES. 1ST. NEW TRACH TUBES INTERMITTENTLY REQUIRED ADDITIONAL WATER AND MASSAGING BEFORE USE. 2ND. NEW TRACH TUBES WERE FOUND?. DEFECTIVE" IN THAT WATER DID NOT ENTER THE LINE TO THE CUFF FROM THE BALLOON. EACH FAULT HAS CAUSED A DELAY IN RESUSCITATION DURING A CRITICAL CHANGE IN WHICH CPR WAS REQUIRED. THE CUSTOMER REPORTED LOT NUMBER 34180462; WHICH CANNOT BE VERIFIED.

  Patient problems: Decreased Respiratory Rate; Respiratory Insufficiency

  MAUDE report 17165119 ↗
• MalfunctionJun 9, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-USE CHECK THE CUFF DID NOT FULLY INFLATE DESPITE "SIGNIFICANT" AIR ADDED AND MANIPULATION OF THE CUFF. PROTOCOL WAS USED AND 10 ML OFF AIR ADDED TO THE CUFF. CUFF WAS MASSAGED AS DIRECTED AND NOT ALL OF THE CUFF INFLATED. PROCEDURE PERFORMED WAS ROUTINE TRACHEOSTOMY CHANGE. EVENT OCCURRED WHILE TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17099410 ↗
• MalfunctionMay 12, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF EXPANDED IN WAY THAT WAS NOT FUNCTIONAL DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918485 ↗
• MalfunctionApr 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE TESTING THE TRACH BALLOON WOULD NOT INFLATE. IT WAS THOUGHT TO BE DEFECTIVE. THE SECOND DEVICE HAD THE SAME ISSUE. THE STAFF PULLED THE THIRD OFF THE SHELF, DUE TO SAME LOT NUMBER, AND REMOVED FROM STOCK UNOPENED. NO INJURY REPORTED. (CC-0192909 REPRESENTS THE FIRST ITEM. CC-0192936 REPRESENTS THE SECOND ITEM, CC-0192943 REPRESENTS THE THIRD ITEM.)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811540 ↗
• MalfunctionApr 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE TESTING THE TRACH BALLOON WOULD NOT INFLATE. IT WAS THOUGHT TO BE DEFECTIVE. THE SECOND DEVICE HAD THE SAME ISSUE. THE STAFF PULLED THE THIRD OFF THE SHELF, DUE TO SAME LOT NUMBER, AND REMOVED FROM STOCK UNOPENED. NO INJURY REPORTED. ((B)(4) REPRESENTS THE FIRST ITEM. (B)(4) REPRESENTS THE SECOND ITEM, (B)(4) REPRESENTS THE THIRD ITEM.).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811468 ↗
• MalfunctionApr 25, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING THE PRE-USE TESTING THE TRACH BALLOON WOULD NOT INFLATE. IT WAS THOUGHT TO BE DEFECTIVE. THE SECOND DEVICE HAD THE SAME ISSUE. THE STAFF PULLED THE THIRD OFF THE SHELF, DUE TO ALL HAVING THE SAME LOT NUMBER, AND REMOVED IT FROM STOCK UNOPENED. NO INJURY REPORTED. ((B)(6) REPRESENTS THE FIRST ITEM, (B)(6) REPRESENTS THE SECOND ITEM, (B)(6) REPRESENTS THE THIRD ITEM).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16811426 ↗
• MalfunctionSep 27, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE CUFF WAS UNABLE TO INFLATE DURING PRE-USE CHECK: NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492149 ↗
• MalfunctionApr 4, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WE HAVE ALSO HAD RECENTLY A SERIES OF TRACHS THAT THE CUFF IS NEARLY IMPOSSIBLE TO INFLATE DESPITE EXCESSIVE PRESSURE ? ALL OF THE WATER VOLUME REMAINS IN THE PILOT BALLOON. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14000548 ↗
• MalfunctionMar 9, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF FAILED TO INFLATE. THE DEFECT WAS DISCOVERED PRIOR TO PLACING IN PATIENT. ANOTHER TRACH WAS BROUGHT TO THE ROOM, TESTED, AND USED ON PATIENT. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13711299 ↗
• MalfunctionAug 20, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE CUFF WAS NOT DEFLATING.

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

  MAUDE report 12350901 ↗
• MalfunctionAug 20, 2021Failure to Deflate; Failure to Deflate

  IT WAS REPORTED THAT THE CUFF WAS NOT DEFLATING.

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

  MAUDE report 12350741 ↗
• MalfunctionSep 16, 2020Pressure Problem; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS HAVING ISSUES RECENTLY. AFTER MASSAGING THE CUFF, THE CUFF WAS NOT INFLATING PROPERLY. WHEN THE WATER IS IN THE PILOT BALLOON IT APPEARS TO BE FULL AND THE CUFF INITIALLY INFLATES PARTS WAY BUT WHEN THE SYRINGE IS REMOVED IT DEFLATES BUT THE PILOT STAYS INFLATED. THE TRACH IN THE PATIENT DEFLATED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541548 ↗
• MalfunctionSep 16, 2020Pressure Problem; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH WAS HAVING ISSUES RECENTLY. AFTER MASSAGING THE CUFF, THE CUFF WAS NOT INFLATING PROPERLY. WHEN THE WATER IS IN THE PILOT BALLOON IT APPEARS TO BE FULL AND THE CUFF INITIALLY INFLATES PARTS WAY BUT WHEN THE SYRINGE IS REMOVED IT DEFLATES BUT THE PILOT STAYS INFLATED. THE TRACH IN THE PATIENT DEFLATED. THERE WERE NO REPORTED ADVERSE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10541519 ↗
• MalfunctionAug 14, 2020Leak/Splash; Defective Component; Leak/Splash; Defective Component

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED TTS WERE REPORTING TWO PEDIATRIC TRACHS WERE BEING TESTED FOR PROCEDURE. THE PATIENT WAS BEING CHANGED FROM A 4.0 PEDS SHILEY UNCUFFED TO THIS TRACH TYPE AND SIZE. PATIENT IS (B)(6) YEAR OLD, 24/7 TRACH AND VENT DEPENDENT. BOTH OF THE CUFFS WERE NOT INFLATING. WITH MANIPULATION, ONE OF THE CUFFS WAS ABLE TO INFLATE AND BE INSERTED INTO THE PATIENT. DESPITE THE SAME MANIPULATION ON THE OTHER CUFF, IT WAS NOT INFLATING AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10409623 ↗
• MalfunctionJan 23, 2019Output Problem; Output Problem

  ADDITIONAL INFORMATION PROVIDED THAT PATIENT IS CURRENTLY RECEIVING CARE IN THE NEONATAL INTENSIVE CARE UNIT. THE INCIDENT WAS REPORTED TO BE RESOLVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8270158 ↗
• InjuryApr 12, 2017Inadequacy of Device Shape and/or Size; Packaging Problem; Inadequacy of Device Shape and/or Size; Packaging Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® NEONATAL AND PEDIATRIC TTS¿ (TIGHT-TO-SHAFT) TRACHEOSTOMY TUBE WAS PLACED IN A PATIENT IN THE OPERATING ROOM AND DURING RESPIRATORY THERAPIST INITIAL ASSESSMENT, IT WAS OBSERVED THAT THE PACKAGING FOR THE TRACHEOSTOMY TUBE WAS LABELED AS NEONATAL, BUT THE DEVICE REFERENCE NUMBER AND LENGTH SPECIFICATIONS WERE CONSISTENT WITH A PEDIATRIC TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE DEVICE WAS MARKED AS 'PEDIATRIC' ON THE FLANGE. THE TUBE WAS CHANGED TO A NEONATAL TUBE. IT WAS UNCLEAR WHAT THE IMPACT TO THE PATIENT WAS.

  Patient problems: Complaint, Ill-Defined; No Information

  MAUDE report 6487515 ↗

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.