Bivona 60P045Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 15021312005769), received between Nov 19, 2018 and Apr 25, 2023 — classified as 2 injuries, 10 malfunctions.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 reports).

2 FDA recall records name this device's identifier, 2 still open.

45 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. How this data works · Data updated Oct 13, 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-2595-2024 · Root cause: Under Investigation by firm · FDA record ↗

2. Aug 22, 2023Open, Classified

   The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

   Z-0205-2024 · Root cause: Labeling mix-ups · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT 11 TRACHEOSTOMY TUBES WITH THE SAME ITEM NUMBER AND LOT NUMBER HAD AN EXPIRATION DATE THAT WAS THE SAME AS THE MANUFACTURE DATE ON THE BOX. NO PATIENT INJURY WAS REPORTED, THE ISSUE WAS DISCOVERED DURING PRE-TESTING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16809713 ↗
• InjuryMar 24, 2023Fracture; Fracture

  IT WAS REPORTED THAT THE BIVONA FLEXTEND 4.5MM PED UNCUFFED TRACH TUBE FLANGE BROKE, CAUSING PATIENT TO DECANNULATE. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16610953 ↗
• MalfunctionFeb 8, 2023Expiration Date Error; Expiration Date Error

  IT WAS REPORTED THAT FIVE BOXES OF TRACHEOSTOMY SHOW EXPIRED ON THE LABEL WITH AN EXPIRATION DATE OF 17 MARCH 2021. HOWEVER, IN THE STATES THAT THE LOT DOES NOT EXPIRE UNTIL 17 MARCH 2026. PHOTO ATTACHED. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16330644 ↗
• MalfunctionOct 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED WHEN THE DEVICE WAS OPENED, IT WAS NOTED THAT THE SHAFT, NEAR THE FLANGE WAS TORN. THIS WAS NOTICED WITH TWO PATIENTS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639278 ↗
• MalfunctionOct 20, 2022Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED WHEN THE DEVICE WAS OPENED, IT WAS NOTED THAT THE SHAFT, NEAR THE FLANGE WAS TORN. THIS WAS NOTICED WITH TWO PATIENTS. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15639257 ↗
• MalfunctionApr 8, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING THE PRE-USE CHECK, A STAIN AND A SCRATCH WERE FOUND IN THE PRODUCT. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14063562 ↗
• MalfunctionJul 5, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT A SMITHS MEDICAL BIVONA UNCUFFED NEONATAL TRACHEOSTOMY TRACHEOSTOMY TUBE SPLIT THROUGH WHERE THE HUB OF THE CONNECTOR AND SHAFT MEET. THE ISSUE WAS DISCOVERED WHEN THE PATIENT'S MOTHER WAS CLEANING THE TUBE SHE HAD JUST REMOVED FROM THE PATIENT'S AIRWAY. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8764157 ↗
• InjuryMay 14, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA UNCUFFED NEONATAL TRACHEOSTOMY TUBE HAD SPLIT COMPLETELY APART, WITH THE ENTIRE DISTAL CANNULA SHAFT DISAPPEARING AND ENTERING INTO THE PATIENT'S LEFT MAIN STEM BRONCHUS. 911 WAS CALLED. THE CHILD WAS BROUGHT TO CHILDREN'S HOSPITAL OF (B)(6). THERE WAS NO RESPIRATORY DISTRESS NOTED. THE REMAINING CANNULA SHAFT WAS REMOVED FROM HER AIRWAY AND A NEW, STERILE 4.5 PEDIATRIC CUFFLESS STANDARD WAS INSERTED INTO HER STOMA. THE CHILD IS BREATHING ON HER OWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8609666 ↗
• MalfunctionApr 20, 2019Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA UNCUFFED NEONATAL TRACHEOSTOMY TUBES TRACHEOSTOMY TUBE SPLIT THROUGH WHERE THE HUB OF CONNECTOR AND SHAFT MEET. THE ISSUE WAS DISCOVERED WHEN PATIENT'S MOTHER WAS CLEANING THE TUBE SHE HAD JUST REMOVED FROM PATIENT'S AIRWAY. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8534286 ↗
• MalfunctionMar 20, 2019Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED FROM A PATIENT'S MOTHER THAT A SMITHS MEDICAL BIVONA UNCUFFED PEDIATRIC TRACHEOSTOMY TUBE CUFF HAD A HOLE IN IT. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8438359 ↗
• MalfunctionNov 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE WAS TORN AT THE BASE WHERE THE TUBE BEGAN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087344 ↗
• MalfunctionNov 19, 2018Material Split, Cut or Torn; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX® BIVONA® UNCUFFED TRACHEOSTOMY TUBE WAS TORN AT THE BASE WHERE THE TUBE BEGAN. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087320 ↗

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-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-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-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-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-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-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-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-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-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-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-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-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-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

…and 30 more.