Bivona 60PFSS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 15021312516791), received between Nov 8, 2017 and Apr 6, 2026 — classified as 18 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. 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-2601-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CHANGE THE PATIENT¿S TRACHEOSTOMY TUBE, BUT THE OBTURATOR DID NOT COME OUT. THIS CAUSED AN EMERGENCY REPLACEMENT, WHICH RESULTED IN THE SAME ISSUE OF THE OBTURATOR BECOMING STUCK. THEY WERE EVENTUALLY ABLE TO CHANGE THE TRACHEOSTOMY TUBE ON THE THIRD ATTEMPT USING AN OLDER TUBE WITHOUT A SHEATH. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789659 ↗
• MalfunctionApr 6, 2026Difficult to Remove

  IT WAS REPORTED THAT WHEN ATTEMPTING TO CHANGE THE PATIENT¿S TRACHEOSTOMY TUBE, BUT THE OBTURATOR DID NOT COME OUT. THIS CAUSED AN EMERGENCY REPLACEMENT, WHICH RESULTED IN THE SAME ISSUE OF THE OBTURATOR BECOMING STUCK. THEY WERE EVENTUALLY ABLE TO CHANGE THE TRACHEOSTOMY TUBE ON THE THIRD ATTEMPT USING AN OLDER TUBE WITHOUT A SHEATH. THERE WAS PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24789467 ↗
• InjuryFeb 26, 2025Break; Crack; Break; Crack

  IT WAS REPORTED THAT THE FLANGE OF TRACHEOSTOMY TUBE FULLY SPLIT AND CAUSED THE TUBE TO COME OUT WHICH REQUIRED AN EMERGENCY TRACHEOSTOMY CHANGE. THE EVENT OCCURRED AT THE PATIENT'S HOME. THERE WAS NO PATIENT HARM REPORTED, AND THE INCIDENT WAS RESOLVED WITH AN EMERGENCY TRACHEOSTOMY TUBE CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21470138 ↗
• MalfunctionJan 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SPLIT WAS OBSERVED ON THE RIGHT SIDE OF THE FLANGE WHILE THE CHILD WAS USING IT. AS A RESULT, AN EMERGENCY TUBE CHANGE WAS PERFORMED. THE TUBE HAS BEEN USED THREE TIMES AND STERILIZED TWICE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139672 ↗
• InjuryOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT THE DEVICE TORE AT THE TRACH TUBE FLANGE EYELET. THE PATIENT HAD TO USE AN ALTERNATE TRACH TUBE. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20561779 ↗
• InjuryJun 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WERE TWO TRACHS WITH BROKEN FLANGES. BOTH TRACHS FAILED WHILE IN USE WITH THE PATIENT WITH NO PATIENT HARM REPORTED. MOREOVER, IT WAS STATED THAT HOME NURSE HAD TO REPLACE BOTH BROKEN TRACHES WITH THEIR LAST PRIMARY BACK-UP ONE DUE TO BROKEN FLANGES ON BOTH UNITS. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM/ADVERSE EVENT REPORTED. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. EMDR-25371 AND EMDR-25636 BOTH REPRESENT THE SAME PATIENT. THIS IS THE FIRST MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533137 ↗
• InjuryJun 13, 2024Fracture; Fracture

  IT WAS REPORTED THAT THERE WERE TWO TRACHS WITH BROKEN FLANGES. BOTH TRACHS FAILED WHILE IN USE WITH THE PATIENT WITH NO PATIENT HARM REPORTED. MOREOVER, IT WAS STATED THAT HOME NURSE HAD TO REPLACE BOTH BROKEN TRACHES WITH THEIR LAST PRIMARY BACK-UP ONE DUE TO BROKEN FLANGES ON BOTH UNITS. THERE WAS PATIENT INVOLVEMENT WITH NO PATIENT HARM/ADVERSE EVENT REPORTED. ONE PATIENT, TWO PRODUCT MALFUNCTIONS. EMDR-25371 AND EMDR-25636 BOTH REPRESENT THE SAME PATIENT. THIS IS THE SECOND MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19533090 ↗
• MalfunctionJun 15, 2023Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE WAS BROKEN. NO PATIENT HARM OR INVOLVEMENT REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17133643 ↗
• MalfunctionJun 12, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE BIVONA TRACH WAS "DEFECTIVE" AND BROKE. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17113031 ↗
• MalfunctionMay 9, 2023Corroded; Degraded; Corroded; Degraded

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL: THE ISSUES WERE NOTICED FOLLOWING STERILIZATION AFTER USE BUT PRIOR TO ANY FURTHER USE AND REMOVED FROM USE IMMEDIATELY. NO INTERVENTION NEEDED BUT FURTHER TRACHEOSTOMY TUBE NEEDED IMMEDIATELY TO REPLACE AFFECTED TUBE. THE EVENT WAS RESOLVED BUT THIS WAS THE THIRD OCCASION THIS HAS HAPPENED WITH THIS PATIENT. NO RELEVANT TESTS/LABORATORY DATA. OTHER RELEVANT HISTORY, INCLUDING PRE-EXISTING CONDITIONS - THE PATIENT REQUIRES A TRACHEOSTOMY TUBE TO MAINTAIN THE AIRWAY DUE TO PHARYNGOMALACIA. HAS CHRONIC LUNG DISEASE FROM PREMATURITY WITH EMPHYSEMATOUS BRONCHOPULMONARY DYSPLASIA, AND SUBGLOTTIC CYSTS. WAS BORN AT 24+5 WEEKS GESTATION AND HAS PREVIOUSLY REQUIRED NON-INVASIVE VENTILATION AT HOME AND OXYGEN ? VENTILATION STOPPED 1 YEAR AGO, AND OXYGEN STOPPED RECENTLY. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) ? THE PATIENT USES TRACHEOSTOMY TUBES, SUCTION CATHETERS, SUCTION MACHINE, NG TUBE AND FEEDING PUMP. THE MEDICATIONS PRESCRIBED AT THE TIME OF INCIDENT WERE OMEPRAZOLE TWICE DAILY, LEVETIRACETAM TWICE DAILY AND AZITHROMYCIN EVERY OTHER DAY. PATIENT INFO WAS ADDED. OCCURRED IN FAMILY HOME. NO ADVERSE PATIEN

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

  MAUDE report 16899312 ↗
• MalfunctionMay 9, 2023Corroded; Degraded; Corroded; Degraded

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL: THE ISSUES WERE NOTICED FOLLOWING STERILIZATION AFTER USE BUT PRIOR TO ANY FURTHER USE AND REMOVED FROM USE IMMEDIATELY. NO INTERVENTION NEEDED BUT FURTHER TRACHEOSTOMY TUBE NEEDED IMMEDIATELY TO REPLACE AFFECTED TUBE. THE EVENT WAS RESOLVED BUT THIS WAS THE THIRD OCCASION THIS HAS HAPPENED WITH THIS PATIENT. NO RELEVANT TESTS/LABORATORY DATA. OTHER RELEVANT HISTORY, INCLUDING PRE-EXISTING CONDITIONS - THE PATIENT REQUIRES A TRACHEOSTOMY TUBE TO MAINTAIN THE AIRWAY DUE TO PHARYNGOMALACIA. HAS CHRONIC LUNG DISEASE FROM PREMATURITY WITH EMPHYSEMATOUS BRONCHOPULMONARY DYSPLASIA, AND SUBGLOTTIC CYSTS. WAS BORN AT 24+5 WEEKS GESTATION AND HAS PREVIOUSLY REQUIRED NON-INVASIVE VENTILATION AT HOME AND OXYGEN ? VENTILATION STOPPED 1 YEAR AGO, AND OXYGEN STOPPED RECENTLY. CONCOMITANT MEDICAL PRODUCTS AND THERAPY DATES (EXCLUDES TREATMENT OF EVENT) ? THE PATIENT USES TRACHEOSTOMY TUBES, SUCTION CATHETERS, SUCTION MACHINE, NG TUBE AND FEEDING PUMP. THE MEDICATIONS PRESCRIBED AT THE TIME OF INCIDENT WERE OMEPRAZOLE TWICE DAILY, LEVETIRACETAM TWICE DAILY AND AZITHROMYCIN EVERY OTHER DAY. PATIENT INFO WAS ADDED. DATE OF EVENT WAS ON 18-APR-2023 AND OCCUR

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

  MAUDE report 16899309 ↗
• MalfunctionApr 14, 2023Product Quality Problem; Product Quality Problem

  IT WAS REPORTED THAT THE ITEM WAS "FAULTY, THE COILS ON DAMAGED FROM PRODUCTION". NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16744072 ↗
• MalfunctionDec 7, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE CORRECT TUBE SHOULD HAVE A STRAIGHT FLANGE BUT A V-SHAPE FLANGE WAS RECEIVED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15937132 ↗
• MalfunctionSep 27, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE TUBE WAS MISLABELED AS 60PFSS45 BUT IS A V FLANGE AND NOT A TTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15492408 ↗
• MalfunctionSep 19, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, IT WAS DISCOVERED THAT PART NUMBER 67PFSS45 WAS FOUND INSIDE THE PACKAGE BUT PART NUMBER 60PFSS45 WAS ORDERED. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15445137 ↗
• MalfunctionSep 16, 2022Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE THE CORRECT TUBE SHOULD HAVE A STRAIGHT FLANGE BUT A V-SHAPE FLANGE WAS RECEIVED. THERE WAS NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437947 ↗
• MalfunctionSep 16, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT UPON OPENING THE PACKAGE, THE LABEL LISTS A STRAIGHT FLANGE BUT THE TRACH RECEIVED HAD A V-FLANGE. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437196 ↗
• MalfunctionAug 23, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE DEVICE WAS LABELLED AS STRAIGHT FLANGE BUT PRODUCT WAS A V FLANGE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280308 ↗
• MalfunctionJun 3, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT THE INTRODUCER GOT LODGED IN THE DURING PRE-USE CHECK. A NEW TUBE WAS TESTED PRIOR TO INSERTION AND WAS USED TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14594898 ↗
• InjuryApr 2, 2021Break; Break

  PARENTS NOTICED TEAR IN THE EYELET. TRACH CHANGE OUT DONE TO RESOLVE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611744 ↗
• InjuryApr 2, 2021Break; Break

  PARENTS NOTICED TEAR STARTING AT FLANGE AREA OF TRACHEOSTOMY WHERE THE NECK TIES INSERTED. DECIDED TO CHANGE THE TRACHEOSTOMY TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611743 ↗
• InjuryApr 2, 2021Break; Break

  PARENTS NOTICED TEAR IN THE EYELET. TRACH CHANGE OUT DONE TO RESOLVE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611738 ↗
• InjuryApr 2, 2021Break; Break

  PARENTS NOTICED TEAR IN THE EYELET. TRACH CHANGE OUT DONE TO RESOLVE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11611736 ↗
• MalfunctionApr 2, 2021Break; Break

  IT WAS REPORTED THAT PARENTS NOTICED TEAR IN THE EYELET. TRACH CHANGE OUT DONE TO RESOLVE ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611734 ↗
• MalfunctionNov 13, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  INVESTIGATION COMPLETED AND NO PRODUCT WAS RETURNED, HOWEVER A PICTURE OF DEVICE TORN WAS. H 10 ENGINEERING SUMMARY OF ANALYSIS .

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10834466 ↗

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.