Bivona 60PFSS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 15021312516777), received between Apr 17, 2018 and Sep 21, 2026 — classified as 20 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 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-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.

• MalfunctionSep 21, 2026Crack

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848350 ↗
• InjuryAug 24, 2026Material Separation

  Patient problems: Loss of consciousness

  MAUDE report 50418696 ↗
• InjuryAug 24, 2026Material Separation

  Patient problems: Loss of consciousness

  MAUDE report 50418549 ↗
• InjuryJun 10, 2026Mechanical Problem

  IT WAS REPORTED THAT A TRACHEOSTOMY TUBE GOT COLLAPSED WHEN IT WAS USED IN A PATIENT WHICH CAUSED GASPING AND MADE THE PATIENT TO CAUSE RESPIRATORY DISTRESS. A MEDICAL INTERVENTION WAS REQUIRED TO REPLACE THE MALFUNCTIONED DEVICE.

  Patient problems: Airway Obstruction

  MAUDE report 25460896 ↗
• MalfunctionJun 1, 2026Gas/Air Leak

  IT WAS REPORTED THAT THE PATIENT HAD REQUIRED AN EMERGENCY TRACH CHANGE DUE TO MUCOUS PLUG. WHEN THE TRACH WAS REMOVED, IT WAS FOUND TO HAVE THE SILICONE ON THE SHAFT BROKEN AND THE COIL WIRE EXPOSED UNDERNEATH IT. PATIENT REQUIRED EMERGENCY TRACH CHANGE DUE TO MUCOUS PLUG, AND WHEN TRACH WAS REMOVED IT WAS NOTED THAT SHAFT WAS BROKEN AND COIL WIRED EXPOSED. NO ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED ONCE TRACH WAS CHANGED. NO DELAY IN THERAPY NOTED. NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25351276 ↗
• MalfunctionOct 29, 2024Fracture; Fracture

  IT WAS REPORTED THAT "ON THE DEVICE FLANGE THE EYELET ON THE LEFT SIDE FACING THE PT HAS BROKEN". THERE WAS PATIENT INVOLVEMENT. ADVERSE PATIENT EFFECTS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20558932 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT HAIRLINE FRACTURES WERE THE TRACHS NEAR THE HUB. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032610 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT HAIRLINE FRACTURES WERE NOTICED ON THE TRACH NEAR THE HUB. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20032072 ↗
• InjuryAug 8, 2024Break; Break

  IT WAS REPORTED THAT AN ALARM WAS ACTIVATED DUE TO AN INCREASE IN ETCO2, AND UPON INVESTIGATION IT WAS NOTICED THAT THE TRACH WAS BROKEN. THE PATIENT HAD A 3.5/40 BIVONA UNCUFFED TRACH AND WAS ADMITTED FROM THE OPERATING ROOM. THE EVENT OCCURRED AT THE HOSPITAL. THERE WAS MEDICAL INTERVENTION REQUIRED, THE PATIENT¿S TRACH WAS CHANGED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19939150 ↗
• MalfunctionJul 11, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE IN USE WITH PATIENT, THE SILICONE ON UNDERNEATH OF TRACHEOSTOMY TUBE SPLIT NEAR ATTACHMENT TO HARD PLASTIC HUB. 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 19726434 ↗
• InjuryFeb 2, 2024Fracture; Material Separation; Fracture; Material Separation

  IT WAS REPORTED THAT THE TRACH TUBE BROKE AT THE EYELET AND THE PATIENT BECAME DECANNULATED. CAREGIVERS HAD TO DO AN EMERGENT TRACH CHANGE TO SUPPORT PATIENT¿S CRITICAL AIRWAY. THE OUTCOME OF THE EVENT WAS REPORTED AS ONGOING AS IT HAS HAPPENED BEFORE. IT WAS UNKNOWN IF PREVIOUS OCCURRENCE(S) WERE REPORTED.

  Patient problems: Airway Obstruction

  MAUDE report 18630941 ↗
• InjurySep 21, 2023Break; Break

  IT WAS REPORTED THAT THE CUSTOMER EXPERIENCED A BROKEN TRACHEOSTOMY TUBE. THE EVENT RESULTED IN AN EMERGENCY TRACHEOSTOMY TUBE CHANGE. PATIENT INVOLVEMENT BUT NO PATIENT OR CLINICAL INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17795106 ↗
• MalfunctionMar 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS DETERMINED THAT THIS EVENT WAS ALREADY REPORTED UNDER CC-0182559.

  Patient problems: Insufficient Information

  MAUDE report 16649859 ↗
• MalfunctionMar 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS DETERMINED THAT THIS EVENT WAS ALREADY REPORTED UNDER (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 16649731 ↗
• MalfunctionMar 30, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS DETERMINED THAT THIS EVENT WAS ALREADY REPORTED UNDER (B)(4).

  Patient problems: Respiratory Arrest; Respiratory Failure

  MAUDE report 16647437 ↗
• MalfunctionMar 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN THE TRACH FLANGE. CUSTOMER IS CONCERNED AS THIS IS AN ONGOING ISSUE. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16468563 ↗
• InjuryFeb 7, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE SNAPPED AT HUB OF CONNECTOR, IN THE PATIENT'S HOME. PARENT BELIEVES THE TUBE SNAPPED DUE TO CHILD PULLING AT TUBE TRYING TO DISCONNECT FROM VENTILATION SUPPORT. THE HUB OF THE TRACHEOSTOMY TUBE DEVICE BROKE OFF FROM THE REST OF THE DEVICE. THE REMAINING ELEMENT OF THE DEVICE REMAINED IN THE STOMA. PATIENT WAS NOT ABLE TO RECEIVE VENTILATION SUPPORT UNTIL AN EMERGENCY TUBE CHANGE HAD BEEN UNDERTAKEN. AN EMERGENCY TUBE CHANGE WAS PERFORMED TO REPLACE THE TUBE IN THE IMMEDIATE INSTANCE AND ENSURED PATIENTS SAFETY. AFTER TUBE CHANGE WAS SUCCESSFULLY COMPLETED, NO CONCERN FOR THE PATIENT REMAINED.

  Patient problems: Decreased Respiratory Rate; Respiratory Failure

  MAUDE report 16313683 ↗
• InjuryJan 27, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE SNAPPED AT HUB OF CONNECTOR, IN THE PATIENT'S HOME. PARENT BELIEVES THE TUBE SNAPPED DUE TO CHILD PULLING AT TUBE TRYING TO DISCONNECT FROM VENTILATION SUPPORT. THE HUB OF THE TRACHEOSTOMY TUBE DEVICE BROKE OFF FROM THE REST OF THE DEVICE. PATIENT WAS NOT ABLE TO RECEIVE VENTILATION SUPPORT UNTIL AN EMERGENCY TUBE CHANGE HAD BEEN UNDERTAKEN. AN EMERGENCY TUBE CHANGE WAS PERFORMED TO REPLACE THE TUBE IN THE IMMEDIATE INSTANCE AND ENSURED PATIENTS SAFETY. AFTER TUBE CHANGE WAS SUCCESSFULLY COMPLETED, NO CONCERN FOR THE PATIENT REMAINED.

  Patient problems: Decreased Respiratory Rate; Respiratory Failure

  MAUDE report 16258529 ↗
• InjuryJan 27, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE SNAPPED AT HUB OF CONNECTOR, IN THE PATIENT'S HOME. PARENT BELIEVES THE TUBE SNAPPED DUE TO CHILD PULLING AT TUBE TRYING TO DISCONNECT FROM VENTILATION SUPPORT. THE HUB OF THE TRACHEOSTOMY TUBE DEVICE BROKE OFF FROM THE REST OF THE DEVICE. THE REMAINING ELEMENT OF THE DEVICE REMAINED IN THE STOMA. PATIENT WAS NOT ABLE TO RECEIVE VENTILATION SUPPORT UNTIL AN EMERGENCY TUBE CHANGE HAD BEEN UNDERTAKEN. AN EMERGENCY TUBE CHANGE WAS PERFORMED TO REPLACE THE TUBE IN THE IMMEDIATE INSTANCE AND ENSURED PATIENTS SAFETY. AFTER TUBE CHANGE WAS SUCCESSFULLY COMPLETED, NO CONCERN FOR THE PATIENT REMAINED.

  Patient problems: Decreased Respiratory Rate; Respiratory Failure

  MAUDE report 16258423 ↗
• MalfunctionJan 19, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT DISCOLORATION OF TRACH TUBE AFTER INSERTION AND UPON REMOVAL OF TRACH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210598 ↗
• MalfunctionJan 19, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT DISCOLORATION OF TRACH TUBE AFTER INSERTION AND UPON REMOVAL OF TRACH. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16210523 ↗
• InjuryAug 29, 2022Break; Break

  IT WAS REPORTED THAT THE TRACH TUBE WING BROKE WHILE IN SITU IN WITH A PATIENT. IT IS UNSURE HOW OR WHEN THE DAMAGE OCCURRED. THE TRACH WAS REPLACED IMMEDIATELY. THERE WAS NO HARM TO THE PATIENT.

  Patient problems: Decreased Respiratory Rate; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312668 ↗
• MalfunctionAug 24, 2022Material Separation; Material Separation

  IT WAS REPORTED THAT THE FLANGE HAS SNAPPED OFF ON THE LEFT SIDE OF THE TUBE. THE REGULATORY AUTHORITY WILL BE NOTIFIED BECAUSE THE PRODUCT FAULT DID OCCUR WHILE IN USE WITH A PATIENT AND FELL OUT WHILE THEY WERE GETTING CHILD OUT OF THE CAR. THE PRODUCT FAULT DID NOT CAUSE OR CONTRIBUTE TO PATIENT OR CLINICAL INJURY BECAUSE IT WAS FOUND VERY QUICKLY AND PARENT WAS ABLE TO INSERT TUBE BACK IN QUICKLY TO MAINTAIN AIRWAY. DUE TO THE PRODUCT FAULT THE CUSTOMER TEAM HAS SUPPLIED A NEW TUBE BUT PARENTAL ANXIETY HAS INCREASED AND NOT HAPPY WITH CURRENT TUBE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15287259 ↗
• InjuryMar 8, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT BIVONA TRACHEOSTOMY TUBE WAS RIGID AND SCRATCHING THE PATIENT'S THROAT. THE TRACH WAS REMOVED AND REPLACED AS A RESULT. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11439586 ↗
• InjuryMar 8, 2021Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT BIVONA TRACHEOSTOMY TUBE WAS RIGID AND SCRATCHING THE PATIENT'S THROAT. THE TRACH WAS REMOVED AND REPLACED AS A RESULT. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11439439 ↗

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.