Bivona 60SP050Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 15021312000405), received between Apr 13, 2017 and May 15, 2026 — classified as 2 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT THE TUBE BROKE AT THE ENDS OF THE FLANGE WHERE THE TRACHEOSTOMY TIES HOLD THE TRACH IN PLACE. THE PATIENT WAS DECANNULATED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185937 ↗
• MalfunctionMay 15, 2026Break

  IT WAS REPORTED THAT THE TRACH TUBE BROKE AT THE ENDS OF THE FLANGE WHERE THE TRACHEOSTOMY TIES HOLD THE TRACH IN PLACE. THE PATIENT WAS DECANNULATED. NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25185775 ↗
• MalfunctionMay 8, 2026Break; Material Puncture/Hole

  IT WAS REPORTED THAT THE NECK HOLDER HOLE ON THE PEDIATRIC TRACHEOSTOMY TUBE COLLAR WAS BROKEN. THERE WAS PATIENT INVOLVEMENT; HOWEVER, NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25128565 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT THE VELCRO TIE TO THE TUBE BROKE WHILE THE DEVICE WAS IN USE WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830712 ↗
• MalfunctionApr 9, 2026Break

  IT WAS REPORTED THAT THE VELCRO TIE TO THE TUBE BROKE WHILE THE DEVICE WAS IN USE WITH THE PATIENT. THERE WAS PATIENT INVOLVEMENT, AND NO PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24830705 ↗
• MalfunctionFeb 16, 2026Break

  IT WAS REPORTED THAT ONE OF THE TRACHEOSTOMY TUBE FASTENING LOOPS BROKE WHILE IT WAS IN USE. PER REPORTER, THE CANNULA HAD BEEN PLACED FOR THE PATIENT ON (B)(6) 2026, AND THE REPLACEMENT INTERVAL IS FOUR WEEKS. NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24343859 ↗
• MalfunctionJul 11, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE DEVICE WAS BEING USED WITH A NECK TAPE TIE WHEN THE OPERATOR NOTICED, THE FLANGE WAS DAMAGED/CUT. THIS OCCURRED DURING USE, AND THERE WAS NO REPORTED PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22481367 ↗
• MalfunctionApr 25, 2025Break; Break

  IT WAS REPORTED THAT THE HOLE IN THE CANNULA'S ATTACHMENT STRAP WAS ABOUT TO BREAK, AND THE NURSE MANAGED TO REPLACE THE CANNULA BEFORE IT COMPLETELY RUPTURED. AS A RESULT, THE TRACHEOSTOMY CANNULA HAD TO BE CHANGED EARLIER THAN USUAL. PICTURE ATTACHED. A SIMILAR CASE WAS OPEN WITH COMPLAINT NUMBER (B)(4). THE EVENT OCCURRED IN THE HOSPITAL AND THERE WAS PATIENT INVOLVEMENT, BUT NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911156 ↗
• InjuryMar 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 JUNE 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 21540505 ↗
• MalfunctionJun 30, 2023Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE FLANGE BROKE WHILE IN PATIENT USE. NO ADVERSE EFFECTS REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 17243548 ↗
• MalfunctionJun 15, 2023Break; Break

  IT WAS REPORTED THAT THE FLANGE BROKE WHILE IN USE WITH THE PATIENT. PATIENT CONSEQUENCE NOT KNOWN AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 17133656 ↗
• InjuryDec 9, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT WHEN THE CAP OF THE TRACHEOSTOMY TUBE IS PULLED, THE NECK PLATE OF THE TRACHEOSTOMY TUBE WAS COMPLETELY TORN OFF ON ONE SIDE. AS A RESULT, THE TRACHEAL CANNULA HAS COME OUT OF THE STOMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15954834 ↗
• MalfunctionApr 13, 2017Torn Material; Torn Material

  IT WAS REPORTED THAT A PORTEX® BIVONA® UNCUFFED NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE HAD ITS "'EARS' WHERE YOU PUT THE TAPE FOR FIXATION TORN". THE EYELETS WERE TORN AFTER 5 DAYS OF DEVICE USE. THE DEVICE WAS REPLACED WITH A NEW ONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6491305 ↗

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-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-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
• 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-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-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-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-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-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-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-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-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-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-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-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

…and 31 more.