Bivona 60PFS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 15021312005868), received between Aug 2, 2017 and Sep 29, 2026 — classified as 5 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Separation” (4 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-2599-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Split, Cut or Torn

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940150 ↗
• MalfunctionAug 24, 2026Incomplete or Inadequate Connection

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50420098 ↗
• MalfunctionMar 12, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE RIPPED AT THE TRACH TIE DURING USE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18886472 ↗
• MalfunctionJul 21, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING BENCH TESTING, AFTER THE USER "PROCESS TRACH 2 TO 3 TIMES, THE TRACH BREAKS RIGHT AT THE BASE OF THE SHAFT." CALLER SAID THAT THEY WERE PROCESSING THE TRACHS ACCORDING TO DIRECTIONS. NO PATIENT INJURY OR ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17371107 ↗
• MalfunctionJul 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING BENCH TESTING, AFTER THE USER "PROCESS TRACH 2 TO 3 TIMES, THE TRACH BREAKS RIGHT AT THE BASE OF THE SHAFT." CALLER SAID THAT THEY WERE PROCESSING THE TRACHS ACCORDING TO DIRECTIONS. NO PATIENT INJURY OR ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349652 ↗
• MalfunctionJul 19, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING BENCH TESTING, AFTER THE USER "PROCESS TRACH 2 TO 3 TIMES, THE TRACH BREAKS RIGHT AT THE BASE OF THE SHAFT." CALLER SAID THAT THEY WERE PROCESSING THE TRACHS ACCORDING TO DIRECTIONS. NO PATIENT INJURY OR ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17349649 ↗
• MalfunctionJul 13, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING BENCH TESTING, AFTER THE USER "PROCESS TRACH 2 TO 3 TIMES, THE TRACH BREAKS RIGHT AT THE BASE OF THE SHAFT." CALLER SAID THAT THEY WERE PROCESSING THE TRACHS ACCORDING TO DIRECTIONS. NO PATIENT INJURY OR ADVERSE EFFECTS HAVE BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17317840 ↗
• MalfunctionSep 16, 2022Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT THERE WAS PRESENCE OF HAIR IN THE STERILE PACKAGING: NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437199 ↗
• InjuryMay 25, 2022Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT THE TRACH TUBE FLANGE SNAPPED WHILE IN USE WITH A PATIENT. THIS TUBE HAD BEEN RE-PROCESSED ONCE. AN EMERGENT TRACH CHANGE WAS PERFORMED. NO PATIENT INJURY REPORTED FROM TRACH CHANGE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14499025 ↗
• InjuryMay 25, 2022Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT THE TRACH TUBE FLANGE SNAPPED WHILE IN USE WITH A PATIENT. THIS RESULTED IN THE NEED FOR AN EMERGENT TRACH CHANGE, NO PATIENT INJURY FROM TRACH CHANGE.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14498554 ↗
• InjuryMay 23, 2022Material Too Rigid or Stiff; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE OBTURATOR WAS STIFF. NO PATIENT HARM, THE TUBE WAS NOT USED ON THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14471435 ↗
• InjuryAug 16, 2019Decrease in Suction; Suction Problem; Infusion or Flow Problem; Decrease in Suction; Suction Problem; Infusion or Flow Problem

  INFORMATION WAS RECEIVED STATING THE DEVICE WAS A SIZE 8.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8903740 ↗
• InjuryNov 7, 2017Connection Problem; Connection Problem

  INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL TRACHEOSTOMY TUBING FROM ANOTHER MANUFACTURER WAS STUCK AND UNABLE TO BE DISCONNECTED FROM THIS TRACHEOSTOMY. THE PROVIDED WEDGE WAS USED AND WAS UNABLE TO DISCONNECT THE TUBING. DUE TO THIS INCIDENT, THIS PATIENT EXPERIENCED DISCOMFORT. AN EMERGENCY TRACHEOSTOMY TUBE CHANGE WAS REQUIRED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Discomfort

  MAUDE report 7007689 ↗
• MalfunctionAug 8, 2017Break; Break

  IT WAS REPORTED THAT THE NECK FLANGE OF A PORTEX® BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE BROKE. THE FAULT WAS DISCOVERED WHEN TRYING TO PERFORM A TRACHEOSTOMY TUBE CHANGE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6773740 ↗
• MalfunctionAug 2, 2017Split; Split

  IT WAS REPORTED THAT THE LOOP OF A BIVONA® UNCUFFED PEDIATRIC FLEXTEND¿ PLUS SILICONE TRACHEOSTOMY TUBE SEEMS TO HAVE SPLIT AFTER USING THE TRACHEOSTOMY TUBE THREE TIMES. IT WAS NOTED THAT IT BROKE IN THE BOX, THE PATIENT'S PARENT SAID IT "POPPED". NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6761464 ↗

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.