Bivona 60PFSS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI 15021312516784), received between Aug 15, 2017 and Jun 11, 2026 — classified as 32 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (21 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, K944178); 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. How this data works · Data updated Oct 13, 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-2601-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 57 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 11, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRACHEAL TUBE WAS BROKEN AT THE PLACE WHERE THE TIES ARE SECURED. THIS ISSUE MAY LEAD TO AIRWAY RESTRICTION FOR THE PATIENT AND, IF THE MALFUNCTION WERE TO RECUR, COULD CAUSE OR CONTRIBUTE TO SERIOUS INJURY OR DEATH. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25468741 ↗
• InjurySep 17, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE BIVONA TRACHEOSTOMY TUBE WAS BROKEN AT THE FLANGE. THE ISSUE WAS NOTICED BY THE CARE AGENCY WHEN CHECKED BEFORE A TUBE CHANGE. THE TRACHEOSTOMY TUBE HAD TO BE CHANGED TO PREVENT ANY ADVERSE EVENTS TO ABILITY TO BREATH. THE EVENT OCCURRED WHILE IN USE WITH THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20237426 ↗
• MalfunctionSep 3, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE'S FLANGE WAS FOUND SPLIT. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM RECORDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20127665 ↗
• InjuryJul 24, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WAS A SPLIT ON THE FLANGE OF THE TRACHEOSTOMY TUBE. THE DEVICE WAS IN USE AND THE PATIENT REQUIRED AN EMERGENCY TUBE CHANGE. THE PATIENT WAS NOT HARMED AND APART FROM THE TUBE BEING CHANGED DID NOT REQUIRE MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817318 ↗
• InjuryJul 17, 2024Break; Break

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS BROKEN OVERNIGHT. THE TUBE HAD TO BE CHANGED OUT IMMEDIATELY FOR PATIENT SAFETY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19766771 ↗
• MalfunctionJul 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE SILICONE UNDERNEATH THE TRACHEOSTOMY TUBE SPLIT NEAR ATTACHMENT ON HARD PLASTIC HUB AND AN EMERGENCY TUBE CHANGE HAD TO BE UNDERTAKEN IMMEDIATELY TO PREVENT ANY HARM FROM OCCURRING. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19726706 ↗
• MalfunctionFeb 1, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THE BIVONA TRACH WAS MALFUNCTIONING. "THE BIVONA TRACH EYELETS HAVE CHANGED IN THEIR DURABILITY. THE LITTLE EYELETS WERE RIPPING CLEAN THROUGH". THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE OUTCOME WAS REPORTED AS ONGOING. "FAMILY REPORTS THEY HAVE MULTIPLE ENCOUNTERS". IT IS UNKNOWN IF THE PREVIOUS OCCURRENCES WERE REPORTED. EXACT WEIGHT IS 12.6 KGS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18625329 ↗
• InjurySep 1, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A BIVONA TRACHEOSTOMY TUBE. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. FOLLOW UP REQUESTS FOR MORE INFORMATION ARE BEING COMPLETED. PATIENT INVOLVEMENT UNKNOWN.

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

  MAUDE report 17670456 ↗
• InjuryAug 23, 2023Break; Break

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION, BUT UNPLANNED TUBE CHANGE UNDERTAKEN TO ENSURE AN INTACT TUBE WAS IN SITU. PATIENT DETAILS UPDATED. EVENT OCCURRED AT PATIENT HOME.

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

  MAUDE report 17607947 ↗
• MalfunctionAug 3, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT UPON OPENING THE CUFFS WERE NOT INFLATING. IT SEEMED LIKE THE CUFF MATERIAL WAS "STUCK" TO THE TRACH. TRIED INFLATING THE CUFF, YET IT WAS NOT INFLATING. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17453732 ↗
• MalfunctionAug 3, 2023Inflation Problem; Physical Resistance/Sticking; Inflation Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT UPON OPENING THE CUFFS WERE NOT INFLATING. IT SEEMED LIKE THE CUFF MATERIAL WAS "STUCK" TO THE TRACH. TRIED INFLATING THE CUFF, YET IT WAS NOT INFLATING. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17453731 ↗
• MalfunctionMay 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE IN USE WITH THE PATIENT, THE TRACH TUBE HAD A SPLIT OR CRACKING ON THE FLANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17010800 ↗
• MalfunctionMay 26, 2023Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE IN USE WITH THE PATIENT, THE TRACH TUBE HAD A SPLIT OR CRACKING ON THE FLANGE. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER.

  Patient problems: Insufficient Information

  MAUDE report 17010786 ↗
• MalfunctionApr 10, 2023Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT AFTER APPROXIMATELY 4 HOURS OF USE, THERE WAS A SPILT IN THE STEM OF THE TRACHEOSTOMY TUBE THAT WAS INSERTED INTO THE TRACHEOSTOMY STOMA. THE TUBE WAS CLEANED AND INSPECTED PRIOR TO INSERTION. WHEN THE CHILD PATIENT WAS UNSETTLED HIS PARENTS DECIDED TO CHANGE THE TUBE. ON REMOVAL THEY NOTED THE SPLIT TO THE TRACHEOSTOMY TUBE. IT WAS REPORTED BY HIS PARENTS THAT "ALTHOUGH THEIR SON WAS VERY UNSETTLED, THERE WERE NO CONCERNS ABOUT THE PATIENT RESPIRATORY EFFORT AT THE TIME." THE TUBE LOOKED SLIGHTLY DISPLACED, HOWEVER THE CUSTOMER FELT THIS WAS POSSIBLY "DOWN TO THE TENSION ON THE TRACHEOSTOMY TAPES AT THE TIME". THERE WAS NO PATIENT HARM THAT OCCURRED. NO MEDICAL INTERVENTION WAS REQUIRED. THE CHILD HAS A COMPLEX AIRWAY WITH NO UPPER AIRWAY FUNCTION. THE TUBE WAS "CHANGED AT THE CHILD'S EDUCATIONAL SETTING AND NOTED ON RETURN WHEN CHANGED BY THE PARENT".

  Patient problems: Irritability

  MAUDE report 16710470 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAS BEEN USING TRACHEOSTOMY TUBES SINCE SEPTEMBER 2020. RECENTLY TRACHEOSTOMY TUBES KEEP BREAKING AT THE FLANGES. A COUPLE OF THE PRODUCTS WERE BRAND NEW BUT BROKE WHEN THE CHILD PATIENT PULLED ON THEM. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16594608 ↗
• MalfunctionMar 22, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT HAS BEEN USING TRACHEOSTOMY TUBES SINCE SEPTEMBER 2020. RECENTLY TRACHEOSTOMY TUBES KEEP BREAKING AT THE FLANGES. A COUPLE OF THE PRODUCTS WERE BRAND NEW BUT BROKE WHEN THE CHILD PATIENT PULLED ON THEM. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16594598 ↗
• InjuryMar 15, 2023Fracture; Sharp Edges; Fracture; Sharp Edges

  IT WAS REPORTED THAT THE PATIENT PARENT NOTICED THAT WIRE WAS SHOWING, AND TUBE BROKEN. EMERGENCY TUBE CHANGE CARRIED OUT. THE PATIENT THEN WENT ON TO BLOCK HER 2ND TUBE AND WENT ON TO HAVE CARDIAC ARREST. NO OTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Cardiac Arrest

  MAUDE report 16549738 ↗
• InjuryJan 25, 2023Obstruction of Flow; Blocked Connection; Obstruction of Flow; Blocked Connection

  IT WAS REPORTED THAT A PATIENT HAD UNDERGONE AN EMERGENT TRACH CHANGE. AFTER SUCCESSFUL PLACEMENT OF THAT TRACH TUBE THE PATIENT THEN WENT ON TO BLOCK THE NEW TUBE THAT HAD JUST BEEN PLACED. THE PATIENT WENT ON TO HAVE CARDIAC ARREST, BUT NOT AT FAULT OF THIS TUBE. CPR CARRIED OUT AND PATIENT WAS RECOVERED QUICKLY.

  Patient problems: Cardiac Arrest

  MAUDE report 16240879 ↗
• InjuryJan 25, 2023Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT THE CUSTOMER (PARENT) NOTICED THAT THE WIRE WAS SHOWING, AND THE TUBE BROKEN. AN EMERGENCY TUBE CHANGE WAS CARRIED OUT.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 16240878 ↗
• MalfunctionOct 31, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE FLANGE HAD A TEAR IN IT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698492 ↗
• MalfunctionOct 13, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A ROUTINE TRACH CHANGE, A TEAR WAS NOTICED ON THE EYELET. NO PATIENT INJURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595481 ↗
• MalfunctionOct 6, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT DURING A ROUTINE TRACH CHANGE, A TEAR WAS NOTICED ON THE EYELET. NO PATIENT INJURE WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15557565 ↗
• MalfunctionSep 14, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT PRIOR TO USE WITH PATIENT, THE PRODUCT BEGAN TO TEAR. A NEW TUBE WAS USED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15418528 ↗
• MalfunctionSep 13, 2022Break; Break

  IT WAS REPORTED THAT THERE IS A SMALL MARK ON THE TUBE THAT IS NOT THE SAME AS THE OTHER PART OF THE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415138 ↗
• MalfunctionAug 8, 2022Deformation Due to Compressive Stress; Material Twisted/Bent; Deformation Due to Compressive Stress; Material Twisted/Bent

  IT WAS REPORTED THAT THE END OF THE TRACH HAS DEFORMITY. THE CUSTOMER GOT IT OUT OF THE BOX AND INSPECTED THE TRACHEOSTOMY TUBE AND SAW THAT THE DISTAL END OF THE TUBE LOOKED KINKED OR IRREGULAR. THE WIRE INSIDE SEEM TO BE BENT AND NOT UNIFORM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188592 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K944178. 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-1145-2021 · Jan 18, 2021 · Terminated
  Tube Tracheostomy and Tube Cuff, Bivona Cuffless Neonatal/Pediatric FlexTend" Tracheostomy Tube (model 60PFS45, lots 3991171, 3991172, and 3988103) V Neck Flange 4.5mm - Product Us
• Z-0726-2021 · Dec 15, 2020 · Terminated
  PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube, REF 60PFSS45
• 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.