Bivona 67PFS35Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 10351688518613), received between Jun 21, 2019 and May 21, 2026 — classified as 1 injury, 18 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (11 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. 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-2613-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 21, 2026Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING AND THE SUCTION TUBE FELT RESISTANCE GOING INTO THE TUBE. THERE WAS UNKNOWN REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25247377 ↗
• MalfunctionMar 13, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT UPON INSTALLATION OF STERILE WATER, THE CUFF PORT BALLOON HYPERINFLATED BEFORE ANY FLUID PROGRESSED THROUGH TO INFLATE THE CUFF. OVER INFLATED CUFF PORT BALLOON DOES NOT INDICATE INFLATED CUFF, THEREFORE THE EXTERNAL MECHANISM FOR CUFF INFLATION ASSESSMENT IS INACCURATE. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596365 ↗
• MalfunctionJan 14, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF INFLATED UNEVENLY, MORE ON ONE SIDE THAN THE OTHER. CAUSED EXCESSIVE LEAKING AND DISCOMFORT TO THE PATIENT. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THE OUTCOME OF THE EVENT WAS RESOLVED.

  Patient problems: Discomfort

  MAUDE report 21152950 ↗
• MalfunctionMar 7, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING DESPITE MASSAGING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496348 ↗
• MalfunctionOct 18, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF COULD NOT BE INFLATED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15625358 ↗
• MalfunctionSep 19, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TWO TRACHEOSTOMY DEVICES HAD ISSUES THAT WERE NOTICED OUT OF THE BOX. THE FIRST DEVICE WAS ASYMMETRICAL WITH ONLY ONE SIDE INFLATING. THE PILOT BALLOON OF THE SECOND DEVICE WAS HOLDING THE WATER IN THE PILOT BALLOON AND NOT INFLATING THE CUFF. NO PATIENT INJURY WAS REPORTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15446192 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE DURING THE PRE-TEST. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436875 ↗
• MalfunctionSep 16, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE DURING THE PRE-TEST. NO PATIENT INJURY OR INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15436870 ↗
• MalfunctionSep 15, 2022Volume Accuracy Problem; Volume Accuracy Problem

  IT WAS REPORTED THAT THE CUFF DID NOT INFLATE DURING PRE-TEST. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433766 ↗
• MalfunctionJul 8, 2022Product Quality Problem; Product Quality Problem

  IT WAS REPORTED BY THE CUSTOMER THAT THE COILED WIRE HAD RECOILED UP INTO PROXIMAL SIDE OF THE TRACH TUBE. THIS WAS NOTICED BY PATIENTS MOTHER BEFORE TUBE CHANGE. THIS COULD HAVE BEEN A DANGER AS WITHOUT REINFORCED COIL WIRE, OCCLUSION COULD HAVE OCCURRED. THIS WAS NOTED DURING THE PRE TEST AND THERE WAS NO INJURY OR ADVERSE AFFECTS TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14955814 ↗
• MalfunctionFeb 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE BALLOON WOULD NOT PROPERLY INFLATE DESPITE DEVICE BEING COMPLETELY FILLED. THERE WAS NO PATIENT INVOLVEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13534820 ↗
• MalfunctionJan 27, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING AS EXPECTED OUT OF BOX.

  Patient problems: Insufficient Information

  MAUDE report 13366423 ↗
• MalfunctionJan 26, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF WAS NOT INFLATING AS EXPECTED OUT OF BOX.

  Patient problems: Insufficient Information

  MAUDE report 13361866 ↗
• MalfunctionJul 9, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND CUFF WOULD NOT INFLATE. CUSTOMER WILL NOT GIVE ANY MORE INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 12144418 ↗
• MalfunctionFeb 21, 2020Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT WHILE CHANGING THE CANNULA, ON A SMITHS MEDICAL BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE THE CUFF INFLATED ASYMMETRICALLY CAUSING LEAKAGE DURING MECHANICAL VENTILATION. A TUBE CHANGE OUT WAS REQUIRED AND RELIEVED CHILD OF REPORTED DISCOMFORT AND ANXIETY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742486 ↗
• MalfunctionOct 10, 2019Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement; Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME FOR SEVERAL DAYS. THE PATIENT'S MOTHER REPORTED THAT WATER FROM THE CUFF KEPT LEAKING BACK INTO THE PILOT BALLOON AND THEN THE TUBE CAME OUT ON ITS OWN. IT WAS STATED THIS HAPPENED THREE TIMES. THERE WERE NO ADVERSE PATIENT EFFECTS. THE REPORTER ALSO NOTED NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176498 ↗
• MalfunctionOct 10, 2019Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement; Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME FOR SEVERAL DAYS. THE PATIENT'S MOTHER REPORTED THAT WATER FROM THE CUFF KEPT LEAKING BACK INTO THE PILOT BALLOON AND THEN THE TUBE CAME OUT ON ITS OWN. IT WAS STATED THIS HAPPENED THREE TIMES. THERE WERE NO ADVERSE PATIENT EFFECTS. THE REPORTER ALSO NOTED NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176495 ↗
• MalfunctionOct 10, 2019Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement; Fluid/Blood Leak; Malposition of Device; Device Dislodged or Dislocated; Unintended Movement

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT AT THEIR HOME FOR SEVERAL DAYS. THE PATIENT'S MOTHER REPORTED THAT WATER FROM THE CUFF KEPT LEAKING BACK INTO THE PILOT BALLOON AND THEN THE TUBE CAME OUT ON ITS OWN. IT WAS STATED THIS HAPPENED THREE TIMES. THERE WERE NO ADVERSE PATIENT EFFECTS. THE REPORTER ALSO NOTED NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9176492 ↗
• InjuryJun 21, 2019Break; Break

  IT WAS REPORTED THAT DURING PATIENT USE, THE SILICONE BROKE OFF OF THE PLASTIC AT THE HUB. A TRACH CHANGE OUT WAS PERFORMED AS A RESULT. NO FURTHER COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8724504 ↗

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.