Bivona 60SP055Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312000436), received between Feb 15, 2018 and Dec 30, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Separation Problem” (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 18, 2026.

Recalls naming this device

1. May 29, 2024Class IOpen, 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.

• InjuryDec 30, 2024Break; Break

  IT WAS REPORTED THAT THE FLANGE ON THE TRACHEOSTOMY TUBE BROKE. THEREFORE, THE TRACHEOSTOMY TUBE WAS NOT SECURED AND WAS REPLACED. THE DURATION OF THE IMPLANTATION WAS 7 MONTHS. THERE WAS PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21036581 ↗
• MalfunctionAug 22, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FLANGE HAD SPLIT AT THE EYELET. THIS WAS THE TUBES FIRST USE - IT HAD BEEN IN FOR 29 DAYS. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT HARM AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034329 ↗
• MalfunctionJun 24, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE, THE PATIENT REMOVED THE TRACHEOSTOMY TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14798742 ↗
• MalfunctionJun 15, 2022Separation Problem; Separation Problem

  IT WAS REPORTED THAT DURING USE, THE PATIENT REMOVED THE TRACHEOSTOMY TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14701841 ↗
• InjuryFeb 15, 2018Split; Split

  INFORMATION WAS RECEIVED INDICATING THAT SPLITS WERE NOTED TO A SMITHS MEDICAL BIVONA® UNCUFFED TRACHEOSTOMY TUBE. SUBSEQUENTLY, THE PATIENT UNDERWENT A TRACHEOSTOMY (TRACH) CHANGE OUT AND RECOVERED FOLLOWING. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient; Respiratory Distress

  MAUDE report 7275067 ↗

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-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-2588-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0
• 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-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-2603-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/Lis
• 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-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-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-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-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-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-2605-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOM
• 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-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

…and 31 more.