Bivona 60PFPS40Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 15021312516838), received between Nov 23, 2021 and Nov 13, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 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-2598-2024 · 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.

• MalfunctionNov 13, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ROUTINE CLEANING AND TAPE CHANGE, SUPPORT STAFF OBSERVED A SPLIT IN THE TRACHEOSTOMY TUBE AT THE POINT WHERE IT WIDENS TO CONNECT TO THE VENTILATOR, ABOVE THE FLANGE. THE VENTILATOR DID NOT ALARM TO INDICATE ANY ISSUE. THE TRACHEOSTOMY TUBE WAS IMMEDIATELY REPLACED WITHOUT COMPLICATION, AND NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23543262 ↗
• MalfunctionJan 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS "DEFECTIVE". PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 18514953 ↗
• MalfunctionJan 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS "DEFECTIVE". TWO DEVICE LOT NUMBERS WERE REPORTED. BOTH DEVICES ARE UNUSED. THE SECOND INVOLVED DEVICE WAS DOCUMENTED ON (B)(4) AND REPRESENTS THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508537 ↗
• MalfunctionJan 12, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE DEVICE WAS "DEFECTIVE". TWO DEVICE LOT NUMBERS WERE REPORTED. BOTH DEVICES ARE UNUSED. THE SECOND INVOLVED DEVICE WAS DOCUMENTED ON (B)(4) AND REPRESENTS THE SAME PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18508095 ↗
• MalfunctionOct 31, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT ON THE OUTSIDE OF THE BOX, THE LOT NUMBER INDICATES THE FLANGE SHOULD BE STRAIGHT. WHEN THE TRACH WAS OPENED, IT WAS NOTED THAT THE FLANGE WAS V-SHAPED INSTEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698355 ↗
• MalfunctionOct 31, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT ON THE OUTSIDE OF THE BOX, THE LOT NUMBER INDICATES THE FLANGE SHOULD BE STRAIGHT. WHEN THE TRACH WAS OPENED, IT WAS NOTED THAT THE FLANGE WAS V-SHAPED INSTEAD. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15698330 ↗
• MalfunctionNov 23, 2021Degraded; Degraded

  IT WAS REPORTED THAT THE TRACH TUBE SEEMS TO BE DETERIORATING. THE CUSTOMER FEELS LIKE THIS COULD POTENTIALLY BE LIFE THREATENING DUE TO THE POSSIBILITY OF THE PATIENT ASPIRATING DEBRIS INTO HER LUNGS. PHOTO ATTACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12863619 ↗

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.