Bivona 67PFSS50Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10351688518712), received between Mar 30, 2017 and Jan 14, 2025 — classified as 9 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (17 reports).

1 FDA recall record name this device's identifier, 1 still open.

1 other recall cover devices cleared under the same FDA submission (K923878); 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-2614-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 14, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PATIENT RECEIVED PRODUCT, PILOT BALLOON FELL OFF TRACH. THE REPORTED FAULT OCCURRED DURING OPENING WHEN THE PILOT BALLOON FELL OFF. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21152946 ↗
• MalfunctionDec 27, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE BALLOON DID NOT INFLATE WHEN IN SITE. THE PROBLEM WAS FIXED BY SWAPPING A NEW TUBE. THERE IS PATIENT INVOLVEMENT, THERE IS NO HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21026685 ↗
• MalfunctionSep 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SPRING WAS BREAKING THROUGH EXTERIOR OF TRACH. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20268460 ↗
• MalfunctionDec 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON THE TRACH WAS DEFECTIVE AND WOULD NOT INFLATE. DISCOVERED BEFORE USE. NO PATIENT HARM, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410976 ↗
• MalfunctionDec 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF ON THE TRACH WAS DEFECTIVE AND WOULD NOT INFLATE. DISCOVERED BEFORE USE. NO PATIENT HARM, NO MEDICAL INTERVENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18410892 ↗
• MalfunctionJun 30, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON ON THE TRACH WILL NOT INFLATE. PATIENT INVOLVEMENT IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17239173 ↗
• MalfunctionJun 29, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WOULD ONLY "BLOW UP" ON ONE SIDE. PATIENT INVOLVEMENT UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17230061 ↗
• MalfunctionApr 17, 2023Defective Device; Defective Device

  IT WAS REPORTED THAT THERE WAS A BAD TRACH. NO HARM DONE TO THE PATIENT, NO MEDICAL INTERVENTION WAS NEEDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16755898 ↗
• MalfunctionOct 12, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING A PRE-INSERTION INFLATION CHECK OF THE DEVICE IT WAS DISCOVERED THAT THE CUFF WAS NOT INFLATING FULLY AND EVENLY AROUND CIRCUMFERENCE OF TRACH TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591523 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15455500 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED A NEW TRACH WAS PUT ON THE PATIENT WHEN THE PARENT NOTICED THAT THE PATIENT STARTED TO DESAT. THE PATIENT THEN HAD TO BE BAGGED WITH A RESUS BAG. THEY REMOVED THE TRACH AND SAW THAT IT WAS NOT FULLY INFLATED. THE PATIENT'S MOTHER THEN TESTED THE BACKUP TRACH THEY HAD AND FOUND IT WOULD NOT FULLY INFLATE EITHER SO MOM PUT THE OLD TRACH BACK IN THE PATIENT. THE MOTHER DID NOT WANT TO DO THIS AS THE OLD TRACH HAS MOLD IN IT. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15437013 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436980 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436914 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DO NOT INFLATE SYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436912 ↗
• MalfunctionSep 13, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE DEVICE IS NOT FULLY INFLATING DURING PRE-TESTING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410698 ↗
• MalfunctionAug 23, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS WERE ASYMMETRICAL UPON INFLATING PRIOR TO USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277287 ↗
• MalfunctionJul 24, 2021Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PILOT BALLOON FELL OFF. CUSTOMER CAN'T LOCATE IT. NO FURTHER INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12222669 ↗
• MalfunctionJan 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND A TEAR IN THE FLANGE WAS NOTED. THE REPORTER STATED A TUBE CHANGE WAS REQUIRED TO MAINTAIN AIRWAY. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 11164846 ↗
• InjuryJan 13, 2021Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT AND A TEAR IN THE FLANGE WAS NOTED. THE REPORTER STATED A TUBE CHANGE WAS REQUIRED TO MAINTAIN AIRWAY. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 11164506 ↗
• InjuryNov 26, 2020Fracture; Fracture

  INVESTIGATION COMPLETED AND SUMMARIZED IN H10.

  Patient problems: Hypoventilation

  MAUDE report 10908912 ↗
• InjuryNov 26, 2020Break; Break

  INVESTIGATION COMPLETED AND SUMMARIZED IN H 10.

  Patient problems: Hypoventilation

  MAUDE report 10908854 ↗
• MalfunctionNov 26, 2020Break; Break

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT. THE REPORTER STATED THE DEVICE FLANGE TORE AND REQUIRED A NEW TUBE BE PLACED. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 10908668 ↗
• InjuryNov 26, 2020Break; Break

  IT WAS REPORTED THE DEVICE WAS IN USE WITH PATIENT. THE REPORTER STATED THE DEVICE FLANGE TORE AND REQUIRED A NEW TUBE BE PLACED. NO FURTHER ADVERSE EFFECTS REPORTED.

  Patient problems: Hypoventilation

  MAUDE report 10908249 ↗
• MalfunctionAug 7, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED THAT CUFF OF DEVICE WAS INFLATING ASYMMETRICALLY AND STICKING TO ONE SIDE OF THE TUBE. IFU SUGGESTED MANIPULATION, BUT IT WAS REPORTED THAT DID NOT WORK. THE URGENT TRACH CHANGE THAT WAS NEEDED COULD NOT BE CARRIED OUT DUE TO TRACH NOT INFLATING PROPERLY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379244 ↗
• MalfunctionAug 7, 2020Device Damaged Prior to Use; Device Damaged Prior to Use

  INFORMATION WAS RECEIVED THAT CUFF OF DEVICE WAS INFLATING ASYMMETRICALLY AND STICKING TO ONE SIDE OF THE TUBE. IFU SUGGESTED MANIPULATION, BUT IT WAS REPORTED THAT DID NOT WORK. THE URGENT TRACH CHANGE THAT WAS NEEDED COULD NOT BE CARRIED OUT DUE TO TRACH NOT INFLATING PROPERLY. NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10379240 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.