Bivona 60PFP60Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15021312516821), received between Mar 26, 2020 and Nov 2, 2022 — classified as 3 injuries.

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. 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-2597-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 2, 2022Break; Defective Device; Break; Defective Device

  IT WAS REPORTED THE TRACHEOSTOMY IN QUESTION BROKE, THE CANNULA CAME AWAY FROM THE ADAPTOR WHERE IT MEETS THE OUTER CANNULA ? AN EMERGENCY TRACHEOSTOMY CHANGE HAD TO BE PERFORMED BUT NO HARM WAS DONE. ONCE THE EMERGENCY TRACHE CHANGE WAS DONE, NO OTHER INTERVENTION/TREATMENT WAS REQUIRED AND THE ISSUES WAS RESOLVED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15716977 ↗
• InjuryMar 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT SMITHS BIVONA® ADULT TTS¿ TRACHEOSTOMY TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS A CHILD MANAGED TO PULL OUT A WIRE ON THE TRACH TUBE CAUSING THE TUBE TO SPLIT AND EMERGENT TRACH CHANGE OUT. REPORTED THE CHILD HURT A FINGER WHEN THIS INCIDENT OCCURRED. PHOTOS SHOW DAMAGE. TRACH CHANGE OUT RESOLVED ISSUE.

  Patient problems: Injury; Laceration(s); Respiratory Distress

  MAUDE report 9887056 ↗
• InjuryMar 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT SMITHS BIVONA® ADULT TTS¿ TRACHEOSTOMY TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS A CHILD MANAGED TO PULL OUT A WIRE ON THE TRACH TUBE CAUSING THE TUBE TO SPLIT AND EMERGENT TRACH CHANGE OUT. REPORTED THE CHILD HURT A FINGER WHEN THIS INCIDENT OCCURRED.

  Patient problems: Injury; Laceration(s); Respiratory Distress

  MAUDE report 9887052 ↗

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.