Bivona 60PFSS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15021312516760), received between Oct 19, 2021 and Apr 17, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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 16, 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-2601-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 17, 2026Disconnection

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE FRACTURED AT THE CONNECTION SITE WHERE THE VENTILATOR CIRCUIT ATTACHES. THIS CREATED A CRITICAL SITUATION, AS THE BREAK CAUSED AN IMMEDIATE DISCONNECTION FROM THE VENTILATOR. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24910711 ↗
• MalfunctionMar 31, 2026Defective Component

  IT WAS STATED THAT THE TRACHEOSTOMY TUBES BROKE OFF AT THE SITE WHERE THE VENTILATOR CIRCUIT WAS CONNECTED. IT WAS A VERY DANGEROUS SITUATION BECAUSE IT SUDDENLY DISCONNECTED THE CHILD FROM THE VENTILATOR, REQUIRING THE PARENT OR CAREGIVER TO QUICKLY REMOVE THE BROKEN TRACH, INSERT A NEW ONE, AND RECONNECT THE VENTILATOR. THERE WERE PATIENT INVOLVEMENT AND NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746037 ↗
• InjurySep 29, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE BROKE WHILE IN THE PATIENTS NECK BLOCKING HIS AIRWAYS, IT WAS STATED THAT THIS HAPPENED TWO TIMES WITH TWO DEVICES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THE SECOND EVENT WAS CAPTURED ON CC-0209118

  Patient problems: Airway Obstruction

  MAUDE report 17848550 ↗
• InjurySep 29, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE BROKE WHILE IN THE PATIENTS NECK BLOCKING HIS AIRWAYS, IT WAS STATED THAT THIS HAPPENED TWO TIMES WITH TWO DEVICES. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER. THE SECOND EVENT WAS CAPTURED ON (B)(6).

  Patient problems: Airway Obstruction

  MAUDE report 17848544 ↗
• InjuryApr 14, 2023Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAVE HAD 2 INCIDENTS OF SPLIT FLANGES ON THE TRACHEOSTOMY TUBES. OCCURRED WHILE IN USE WITH PATIENT, A TRACH TUBE WAS REQUIRED. NO PATIENT INJURY REPORTED. (B)(4) DOCUMENTS THAT FIRST PRODUCT MALFUNCTION AND (B)(4) DOCUMENTS THE SECOND PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746926 ↗
• InjuryApr 14, 2023Fracture; Material Split, Cut or Torn; Fracture; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE CUSTOMER HAD 2 INCIDENTS OF SPLIT FLANGES ON THE TRACHEOSTOMY TUBES. OCCURRED WHILE IN USE WITH PATIENT, A TRACH TUBE CHANGE WAS REQUIRED. NO PATIENT INJURY REPORTED. (B)(4) DOCUMENTS THAT FIRST PRODUCT MALFUNCTION AND (B)(4) DOCUMENTS THE SECOND PRODUCT MALFUNCTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16746817 ↗
• MalfunctionOct 19, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT A ROUTINE TRACH CHANGE WAS BEING DONE ON (B)(6) 2021. THROUGHOUT THE DAY, THE FAMILY NOTICED THE PATIENT BEING MORE VOCAL THAN USUAL. WHEN ASLEEP, THE PATIENT STARTED SHOWING SIGNS OF RESPIRATORY DISTRESS. TO TROUBLESHOOT, THE FAMILY MADE SURE THE TRACH WAS IN THE NECK PROPERLY AND THAT THEY COULD PASS A SUCTION CATHETER THROUGH IT. AS A PRECAUTION, FAMILY DID ANOTHER TRACH CHANGE AND THE PATIENT STABILIZED AFTER THAT. WHILE EXAMINING THE OLD TRACH, A FLAP OF CLEAR THIN FLEXIBLE PLASTIC WAS FOUND IN THE INNER WALL OF THE CANNULA. IT WAS ASSUMED THAT WHEN THE PATIENT TOOK IN A BREATH, THE FLAP WOULD GO UP AND ALLOW AIRFLOW BUT WHEN EXHALING, THE FLAP WOULD GO DOWN AND CLOSE OFF OR LIMIT AIRFLOW.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12657996 ↗

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.