Bivona 60SP030Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312000368), received between Jun 25, 2020 and Apr 22, 2024 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Fracture” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT 18 DAYS AFTER INSERTION, A CRACK WAS DISCOVERED IN THE LEFT WING OF THE TRACHEA, IT IS ONLY VISIBLE WHEN YOU FOLD THE WING A LITTLE. IT WAS URGENTLY REPLACED WITH A NEW ONE¿. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160602 ↗
• MalfunctionNov 28, 2023Break; Fracture; Material Separation; Break; Fracture; Material Separation

  IT WAS REPORTED THAT "THE COLLAR CRACKED WHILE THE TUBE WAS CHANGED¿. THE EVENT OCCURRED AT THE PATIENT¿S HOME DURING PATIENT USE. ADVERSE PATIENT EFFECTS ARE UNKNOWN. THE CUSTOMER STATED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 18217224 ↗
• MalfunctionJun 26, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

  3/3 REFERENCE CC-0073132 FOR ALL ATTACHMENTS AND RELATED COMPLAINTS. DAMAGE TO THE HUB WAS FOUND AFTER ONE WEEK OF USE. CAREGIVER STATES THAT PROPER CLEANING PROCEDURES ARE FOLLOWED AND NO EXTERNAL ATTACHMENTS ARE BEING USED. PICTURES ATTACHED. ADDITIONAL INFORMATION RECEIVED 01 JUNE 2020 BY PHONE CALL: THE TWO DEVICES THAT WERE SENT IN ALSO HAD THE SAME ISSUE AS ABOVE. THE TEAR WAS FOUND IN THE SAME PLACE IN ALL THREE TRACHS. THE PATIENT'S MOTHER DID NOT DO TRACH CHANGES STATING THAT THE PATIENT WAS NOT IN DISTRESS. NORMAL TRACH CHANGES WERE DONE WHEN THE PATIENT WAS DUE FOR HER TRACH CHANGES. INVESTIGATION COMPLETED AND IN H 1-.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10200321 ↗
• MalfunctionJun 25, 2020Material Split, Cut or Torn; Material Split, Cut or Torn

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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10198184 ↗

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-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-2604-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM AIRE-CUF , Product Code/List Number/Item Code 65P025; b) PAED. TRACHEOSTOMY TUBE 3.0MM AIR
• 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-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-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-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-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-2606-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List N
• 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-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-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-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-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-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

…and 31 more.