Bivona 60P055Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 15021312005783), received between Jul 13, 2018 and Jan 12, 2026 — classified as 3 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (5 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-2595-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 12, 2026Break

  THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN REPLACING THE BELT, IT BROKE WHEN TRYING TO THREAD IT THROUGH THE HOLE. THIS OCCURRED AT THE FACILITY. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INVESTIGATION: DURING VISUAL INSPECTION, IT WAS IDENTIFIED THAT ONE OF THE FLANGE EYELETS WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24037104 ↗
• MalfunctionJan 17, 2024Structural Problem; Material Split, Cut or Torn; Structural Problem; Material Split, Cut or Torn

  IT WAS STATED THAT A "WIRE WAS COMING OUT OF BOTH THE ONE AND THE OTHER CANNULA". THE EVENT DATE, LOT NUMBER AND PATIENT INVOLVEMENT ARE UNKNOWN. NO HARM HAS BEEN REPORTED. THE PRODUCT WILL BE AVAILABLE FOR INVESTIGATION AFTER THE DISTRIBUTOR WILL RECEIVE IT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18530084 ↗
• MalfunctionDec 28, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT SEVENTEEN TRACHEOSTOMIES WERE NOT INFLATING SYMMETRICALLY WHEN TESTED. ONE OF THE ISSUES WAS FOUND WHILE IN USE. THE REST OF THE ISSUES WERE FOUND DURING PRE TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16061387 ↗
• InjuryOct 31, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING USE, THE CUSTOMER FOUND IT DIFFICULT TO INSERT THE PRODUCT INTO THE PATIENT. THE CUSTOMER ALSO NOTICED THAT THE PATIENT HAD TROUBLE DISCHARGING SPUTUM. THE CUSTOMER CHECKED THE DEVICE AND FOUND A PROTRUSION IN IT. THE DEVICE WAS EXCHANGED TO RESOLVE THE ISSUE WITH NO PATIENT INJURY. NO PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 12725661 ↗
• MalfunctionAug 22, 2019Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT THE LOWER SHAFT OF THE CANNULA WAS DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES WERE TAKEN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923208 ↗
• MalfunctionAug 22, 2019Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT THE LOWER SHAFT OF THE CANNULA WAS DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES WERE TAKEN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923203 ↗
• MalfunctionAug 22, 2019Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT THE LOWER SHAFT OF THE CANNULA WAS DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES WERE TAKEN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923202 ↗
• MalfunctionAug 22, 2019Material Discolored; Material Integrity Problem; Material Discolored; Material Integrity Problem

  IT WAS REPORTED THAT THE LOWER SHAFT OF THE CANNULA WAS DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES WERE TAKEN. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8923200 ↗
• InjuryMar 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS NOTED TO HAVE FUNGUS LIKE SUBSTANCE IN THE TUBE. THE TRACHEOSTOMY TUBE WAS CHANGED OUT, AND NO PATIENT ADVERSE EFFECTS RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446378 ↗
• InjuryMar 22, 2019Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY WAS NOTED TO HAVE FUNGUS LIKE SUBSTANCE IN THE TUBE. THE TRACHEOSTOMY TUBE WAS CHANGED OUT, AND NO PATIENT ADVERSE EFFECTS RESULTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8446375 ↗
• MalfunctionJan 7, 2019Optical Discoloration; Optical Discoloration

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE HAD FIVE CANNULAS OF THE LOWER SHAFT DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES HAD BEEN TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8222536 ↗
• MalfunctionJan 2, 2019Optical Discoloration; Optical Discoloration

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE HAD FIVE CANNULAS OF THE LOWER SHAFT DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES HAD BEEN TAKEN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8209187 ↗
• MalfunctionJan 2, 2019Optical Discoloration; Optical Discoloration

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE HAD FIVE CANNULAS OF THE LOWER SHAFT DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES HAD BEEN TAKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8209179 ↗
• MalfunctionJan 2, 2019Optical Discoloration; Optical Discoloration

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE HAD FIVE CANNULAS OF THE LOWER SHAFT DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES HAD BEEN TAKEN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8209178 ↗
• MalfunctionJan 2, 2019Optical Discoloration; Optical Discoloration

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL TRACHEOSTOMY TUBE HAD FIVE CANNULAS OF THE LOWER SHAFT DISCOLORED AND ROUGH AFTER TWO WEEKS OF USE. NO REPROCESSING MEASURES HAD BEEN TAKEN.

  Patient problems: No Information; No Known Impact Or Consequence To Patient

  MAUDE report 8209177 ↗
• MalfunctionJul 13, 2018Degraded; Material Discolored; Contamination /Decontamination Problem; Degraded; Material Discolored; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE SURFACE OF THE INSERTED PART OF THE TRACHEAL CANNULA CHANGED BY BECOMING ROUGH AND DISCOLORED WITHIN 1-2 WEEKS OF USE. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7687400 ↗

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-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-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-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-2609-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE , Product Code/List Number/Item Code 67NFPS25; b) NEONATA
• 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-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-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-2602-2024 · May 29, 2024 · Open, Classified
  PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5 UNCUFFED NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60SN025; b) 3.0 UNCUFFED NEONATAL TRACHEOST
• 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-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-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-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-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-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.