Bivona 60SP035Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 15021312000375), received between May 17, 2017 and Oct 23, 2025 — classified as 3 deaths, 16 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

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

46 other recalls cover devices cleared under the same FDA submission (K083641, K912469); 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-2602-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DEVICE SPLIT APART AND DISLODGED. THE INTERVENTION REQUIRED WAS DONE BY A TRAINED CAREGIVER, THE PATIENTS' MOM - WHO WAS ALSO A NURSE PRACTITIONER. THE OUTCOME OF THE EVENT WAS RESOLVED. THERE WAS HISTORY OF CRANIOFACIAL MALFORMATIONS RESULTING IN NONPATENT UPPER AIRWAY. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED. PATIENT'S INITIAL WAS HK, DATE OF BIRTH WAS ON (B)(6) 2023, 31 POUNDS, CAUCASIAN, NOT HISPANIC AND G-TUBE DEPENDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23372599 ↗
• MalfunctionMar 12, 2025Crack; Crack

  IT WAS REPORTED THAT THERE IS A BROKEN CANNULA PORTEX PEDIATRIC TRACHEOSTOMY TUBE. THERE IS A CRACK IN THE WING NEXT TO THE "CHIMNEY". THIS OCCURRED DURING PATIENT USE AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21586927 ↗
• MalfunctionOct 11, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE WING OF THE CANNULA. THE EVENT OCCURRED WHILE IN USE WITH PATIENT AND THERE WAS NO HUMAN HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20431185 ↗
• MalfunctionSep 24, 2024Crack; Crack

  IT WAS REPORTED THAT THERE WAS A CRACK IN THE LEFT WING. THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20291416 ↗
• MalfunctionJul 2, 2024Break; Break

  IT WAS REPORTED THAT THE CANNULA WAS STARTING TO BREAK DURING DRESSING. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19660712 ↗
• MalfunctionFeb 12, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING IMMEDIATELY ON USE, "THE LAST FEW TIMES" THE CANNULA WAS CRACKED WITHOUT TOUCHING THE CANNULA. THE PATIENT NEVER EXPERIENCED ANY PROBLEMS WITH THE CANNULA UNTIL NOW BUT THIS TIME THE CANNULA WAS TORN. NO MEDICAL INTERVENTION WAS REQUIRED. THERE ARE TWO POSSIBLE AFFECTED SAMPLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18689122 ↗
• MalfunctionMay 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THAT DURING THE PRE-TEST. THE CUSTOMER FOUND TWO TRACH TUBES WITH SLIGHT CURVES ON THEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16915387 ↗
• MalfunctionMay 11, 2023Material Twisted/Bent; Material Twisted/Bent

  IT WAS REPORTED, THAT DURING THE PRE-TEST. THE CUSTOMER FOUND TWO TRACH TUBES WITH SLIGHT CURVES ON THEM. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16912866 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT THE FLANGE BROKE LEADING TO A TRACH CHANGE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657954 ↗
• MalfunctionOct 19, 2021Break; Break

  IT WAS REPORTED THAT THE FLANGE BROKE LEADING TO A TRACH CHANGE TO RESOLVE THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657898 ↗
• MalfunctionApr 30, 2021Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE HAD AN EYELET TORN IN HALF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 11751019 ↗
• MalfunctionApr 9, 2021Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED EYELET WAS TORN OPEN. EMERGENCY TRACH CHANGE HAD TO BE DONE.

  Patient problems: Airway Obstruction

  MAUDE report 11645369 ↗
• DeathJan 28, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT A DEVICE FOR MEASURING BLOOD OXYGEN AND HEARTBEAT OF A MALE INFANT PATIENT ISSUED AN ALARM. IMMEDIATELY, A MEDICAL STAFF PERSON FOUND THE ISSUE (SMITHS MEDICAL THE TUBE WAS DISCONNECTED) AND GAVE LIFE-SAVING MEDICAL CARE. THE CUSTOMER CHANGED AN EMERGENCY-USE TUBE TWICE, BUT WHEN HE FED OXYGEN INTO THE PATIENT USING THE TUBE, IT WAS NOT INSERTED INTO HIS TRACHEA. 2 HOURS LATER, THE PATIENT PASSED AWAY.

  Patient problems: Death; Sudden Cardiac Death

  MAUDE report 11241973 ↗
• DeathJan 28, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT A DEVICE FOR MEASURING BLOOD OXYGEN AND HEARTBEAT OF A MALE INFANT PATIENT ISSUED AN ALARM. IMMEDIATELY, A MEDICAL STAFF PERSON FOUND THE ISSUE (SMITHS MEDICAL THE TUBE WAS DISCONNECTED) AND GAVE LIFE-SAVING MEDICAL CARE. THE CUSTOMER CHANGED AN EMERGENCY-USE TUBE TWICE, BUT WHEN HE FED OXYGEN INTO THE PATIENT USING THE TUBE, IT WAS NOT INSERTED INTO HIS TRACHEA. 2 HOURS LATER, THE PATIENT PASSED AWAY.?

  Patient problems: Death; Sudden Cardiac Death

  MAUDE report 11241957 ↗
• DeathJan 28, 2021Loose or Intermittent Connection; Connection Problem; Loose or Intermittent Connection; Connection Problem

  IT WAS REPORTED THAT A DEVICE FOR MEASURING BLOOD OXYGEN AND HEARTBEAT OF A MALE INFANT PATIENT ISSUED AN ALARM. IMMEDIATELY, A MEDICAL STAFF PERSON FOUND THE ISSUE (SMITHS MEDICAL THE TUBE WAS DISCONNECTED) AND GAVE LIFE-SAVING MEDICAL CARE. THE CUSTOMER CHANGED AN EMERGENCY-USE TUBE TWICE, BUT WHEN HE FED OXYGEN INTO THE PATIENT USING THE TUBE, IT WAS NOT INSERTED INTO HIS TRACHEA. 2 HOURS LATER, THE PATIENT PASSED AWAY.

  Patient problems: Death; Sudden Cardiac Death

  MAUDE report 11241941 ↗
• MalfunctionAug 19, 2019Crack; Crack

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE WAS FOUND TO BE CRACKED. SUBSEQUENTLY, THE TRACH TUBE WAS REMOVED AND REPLACED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8907164 ↗
• MalfunctionOct 8, 2018Defective Component; Defective Component

  INFORMATION WAS RECEIVED THAT THE BIVONA TRACHEOSTOMY TUBE HAD A BROKEN OBTURATOR IN THE PACKAGE. NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient; No Patient Involvement

  MAUDE report 7944711 ↗
• MalfunctionMay 17, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT'S PARENTS COULD NOT REMOVE THE HEAT MOISTURE EXCHANGER (HME) FROM THE HUB OF A PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE EVENT RESULTED IN "DECANNULATION". NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01052.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573171 ↗
• MalfunctionMay 17, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT THE PATIENT'S PARENTS COULD NOT REMOVE THE HEAT MOISTURE EXCHANGER (HME) FROM THE HUB OF A PORTEX® BIVONA® UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE. IT WAS NOTED THAT THE EVENT RESULTED IN "DECANNULATION". NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-01053.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6573158 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K912469. One submission often covers many models, so check the product and lot details in each record.

• Z-2593-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
• Z-2604-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIR
• Z-2609-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATA
• Z-2601-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND
• Z-2610-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Nu
• Z-2595-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNC
• Z-2591-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item
• Z-2608-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEO
• Z-2603-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/Lis
• Z-2605-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOM
• Z-2606-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List N
• Z-2594-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT T
• Z-2590-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
• Z-2597-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
• Z-2615-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL T

…and 31 more.