Bivona 60PFS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312005851), received between May 9, 2022 and Mar 20, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2023Material Discolored; Material Discolored

  IT WAS REPORTED THAT POST REPROCESSING OF THE TUBE A DISCOLORATION OF THE SILICONE IMMEDIATELY BELOW THE FLANGE AREA (YELLOW TINGE) IS NOTED. THE MORE TIMES WE REPROCESS THE TUBES THE DISCOLORATION BECOMES MORE PRONOUNCED. THERE HAS BEEN NO REPORT OF PATIENT INJURY OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16576744 ↗
• MalfunctionOct 19, 2022Material Disintegration; Material Disintegration

  IT WAS REPORTED THAT THE OUTER COATING WAS BREAKING UP. THE TUBE HAD BEEN CHANGED TWICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15635395 ↗
• InjuryMay 26, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A BIVONA TRACH TUBE HAS SPLIT. THE CUSTOMER NOTICED A SPLIT AT THE END OF THE TRACHEOSTOMY TUBE (WHERE YOU CONNECT THE SWEDISH NOSE OR VENTILATOR TUBING). AN EMERGENCY TRACH CHANGE WAS PERFORMED. LOT NUMBER IS NOT KNOWN. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 14517220 ↗
• InjuryMay 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHILE IN PATIENT USE IT WAS NOTICED THE TRACH TUBE HAD SPLIT. IT WAS NOTICED THE PATIENT HAD INCREASED SECRETIONS AND WERE NOT CLEARING EFFECTIVELY, IT WAS ALSO NOTICED THE PATIENT LOOKED DISTRESSED AND PUFFY EYED. IT WAS THEN REALIZED THE TRACHEOSTOMY TUBE HAD SPLIT AND HAD TO CARRY OUT AN EMERGENCY TUBE CHANGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14336846 ↗

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.