Bivona 60SN040Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312000184), received between Apr 3, 2021 and May 3, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 3, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, THE CUSTOMER NOTICED A PRODUCT WITH CUFF WAS ENCLOSED IN THE PACKAGE. HOWEVER, THE PRODUCT MODEL NUMBER PRINTED ON IT WAS ONE WITHOUT CUFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861933 ↗
• InjuryApr 3, 2021Break; Break

  PARENTS NOTICED TEAR IN EYELET IN AT LEAST FOUR TRACH TUBES. DECIDED TO CHANGE THE TRACHEOSTOMY TUBE EACH TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611756 ↗
• InjuryApr 3, 2021Break; Break

  PARENTS NOTICED TEAR IN EYELET IN AT LEAST FOUR TRACH TUBES. DECIDED TO CHANGE THE TRACHEOSTOMY TUBE EACH TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611755 ↗
• InjuryApr 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PARENTS NOTICED TEAR IN EYELET IN AT LEAST FOUR TRACH TUBES. DECIDED TO CHANGE THE TRACHEOSTOMY TUBE EACH TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611749 ↗
• InjuryApr 3, 2021Patient Device Interaction Problem; Patient Device Interaction Problem

  PARENTS NOTICED TEAR IN EYELET IN AT LEAST FOUR TRACH TUBES. DECIDED TO CHANGE THE TRACHEOSTOMY TUBE EACH TIME. NNO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11611748 ↗

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-2598-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 4.0MM FLEXTEND PEDIATRIC PLUS STRAIGHT TRACH TUBE , Product Code/List Number/Item Code 60PFPS40; b) 4.5MM FLEXTEND PEDI
• 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-2599-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY
• 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-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-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-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-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
• 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-2612-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS STRAIGHT FLANGE , Product Code/List Number/Item Code 67PFPS40; b) PE
• Z-2593-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
• 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-2600-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code
• Z-2589-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RAN
• 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

…and 31 more.