Bivona 60SP045Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15021312000399), received between Feb 8, 2017 and Sep 22, 2026 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

46 other recalls cover devices cleared under the same FDA submission (K083641, K912469); 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-2602-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50860457 ↗
• MalfunctionNov 21, 2025Defective Component; Defective Component

  IT WAS STATED THAT WHEN IT WAS INSERTING THE NEW TRACHEOSTOMY IT WAS NOTICED THE LOOPS WHERE THE TRACHE TIES GO THROUGH WERE DAMAGED ON THE LEFT SIDE ESPECIALLY AND WAS ALMOST SEVERED, THE RIGHT SIDE WAS DAMAGED BUT NOT SEVERED. THERE WERE A PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23617731 ↗
• MalfunctionSep 5, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT ONE MONTH AFTER USE, THE PART WHERE THE FLANGE'S STRING PASSES THROUGH TORE. THE EVENT OCCURRED DURING USE, AND THERE WAS NO REPORTED PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22977117 ↗
• MalfunctionJul 24, 2025Crack; Crack

  IT WAS REPORTED AFTER INSERTING INTO THE PATIENT, THE OPERATOR PASSED THE NECK TAPE, BUT WHEN CHECKED BECAUSE THE STRING CAME OFF, AND THEY FOUND A CRACK IN THE HOLE FOR PASSING THE FLANGE'S NECK TAPE. THIS OCCURRED DURING USE. THERE WAS NO PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592211 ↗
• MalfunctionMar 6, 2025Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAD A REACTION TO THE TUBE, AND STOMA SITE INFLAMED AND APPEARED INFECTED. THE PATIENT SEEMED TO EXPERIENCE THE ISSUES INTERMITTENTLY SINCE (B)(6) 2022 WITH THE DEVICE. THE EVENT OCCURRED IN THE PATIENT'S HOME. THE PATIENT HAS COMPLEX MEDICAL NEEDS AND ONGOING MEDICAL INTERVENTIONS. ENT ARE DUE TO ASSESS PATIENT AND DERMATOLOGY TO REVIEW MAY NEED SURGICAL INTERVENTION.

  Patient problems: Inflammation

  MAUDE report 21540532 ↗
• MalfunctionOct 15, 2024Crack; Crack

  IT WAS REPORTED THAT THE FLANGE CRACKED AND BROKE. WHEN IT BROKE, THE PATIENT WAS ABLE TO HOLD THE TUBE DOWN WITH THEIR HAND AND PREVENT IT FROM BEING REMOVED BY THEMSELVES. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20452362 ↗
• MalfunctionMay 3, 2023Material Separation; Material Separation

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE FLANGE GOT TORN OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16862047 ↗
• MalfunctionFeb 8, 2017Cut In Material; Cut In Material

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE HAD A CUT IN THE FLANGE'S HOLE. THIS INCIDENT WAS OBSERVED BY HOSPITAL PERSONNEL DURING USE WHEN THERE WAS AN ATTEMPT TO REPLACE THE TRACHEOSTOMY TUBE HOLDER. THE CUFF HAD BEEN FILLED WITH AIR AND A COMPETITOR'S HOLDER HAD BEEN USED. IT WAS UNKNOWN IF THE NECK HOLDER HAD TO BE ADJUSTED AT ANY TIME. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A NEW TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6312309 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K912469. One submission often covers many models, so check the product and lot details in each record.

• Z-2611-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE , Product Code/List Number/Item Code 67PFP40; b) PEDIATRIC
• Z-2608-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V FLANGE , Product Code/List Number/Item Code 67NFP25; b) NEONATAL TRACHEO
• Z-2610-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS PEDIATRIC TRACH TUBE , Product Code/List Number/Item Code 67P025; b) TTS PEDIATRIC TRACH TUBE , Product Code/List Nu
• Z-2592-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUB
• Z-2594-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND NEO STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60NFPS30; b) 3.5MM FLEXTEND NEO STRAIGHT T
• Z-2614-2024 · May 29, 2024 · Open, Classified
  a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT NECK , Product Code/List Number/Item Code 67PFSS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND STRAIGHT NECK , Pr
• Z-2613-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOS
• Z-2601-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 3.0MM FLEXTEND PEDIATRIC STANDARD STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFSS30; b) 3.5MM FLEXTEND
• Z-2595-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM UNCUFFED , Product Code/List Number/Item Code 60P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM UNC
• Z-2597-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 6.0MM FLEXTEND PEDIATRIC PLUS VEE TRACH TUBE , Product Code/List Number/Item Code 60PFP60
• Z-2596-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 4.0MM FLEXTEND PLUS, Product Code/List Number/Item Code 60PFP40; b) PAED. TRACHEOSTOMY TUBE 4.0M
• Z-2591-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item
• Z-2615-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 67SN025; b) 3.0mm TTS CUFFED NEONATAL T
• Z-2607-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
• Z-2590-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025

…and 31 more.