Bivona 67PFSS55Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10351688518729), received between Apr 10, 2018 and Nov 11, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 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-2614-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 11, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE CUFF WAS BROKEN. THERE WAS PATIENT INVOLVEMENT, BUT NO HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523458 ↗
• MalfunctionNov 10, 2025Retraction Problem; Retraction Problem

  IT WAS REPORTED THAT THE ISSUE IS THAT THE PILOT PORT WAS RETRACTING INTO THE PILOT BALLOON WHEN INFLATED WITH WATER. DEVICE RETRIEVED FROM THE PATIENT AND SUPPLIED A NEW ONE. THE PATIENT HAS USED IT FOR 4 TIMES. PATIENT IS SAFE, DEVICE REMOVED FROM THE HOUSE. DATIX TO BE DONE AND TERTIARY HOSPITAL INFORMED ABOUT THE PROBLEM. DEFECTIVE DEVICE REMOVED FROM THE PATIENT AND NEW ONE PROVIDED. THE DEFECT WAS FOUND WHEN THE TUBE WAS IN SITU OF THE PATIENT. ONLY 1 ITEM WAS AFFECTED, WHICH WAS USED FOR 4 WEEKS ONLY. IT WAS FOUND BY PARENTS AND REPLACED IT WITH A NEW TUBE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE VENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23511069 ↗
• MalfunctionNov 20, 2024Inflation Problem; Inflation Problem

  IT WAS STATED THAT THE CUFF WAS NOT INFLATING PROPERLY, UNEVENLY. THE PRODUCT FAULT OCCURRED WHILE IN USE WITH A PATIENT. THERE WAS MEDICAL INTERVENTION WHEN THE PATIENT EXPERIENCED DISCOMFORT. THE TRACH WAS REMOVED AND EXCHANGED FOR A DIFFERENT BRAND. OUTCOME OF THE EVENT WAS RESOLVED WITH ALTERNATIVE TRACH.

  Patient problems: Discomfort

  MAUDE report 20736713 ↗
• MalfunctionAug 14, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEAL CANNULA WAS DEFECTIVE AND COULD NOT BE FULLY INFLATED. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19982992 ↗
• InjuryJan 19, 2024Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE CUSTOMER NOTICED A SPONTANEOUS LEAK EITHER IN THE CUFF OR IN THE BLOCKER LINE AFTER THREE MONTHS OF USE. THE CUSTOMER DID NOT KNOW THE NUMBER OF PREPARATIONS NOR THE TYPE OF PROCESSING. THERE WAS PATIENT INVOLVEMENT. THE PATIENT REQUIRED REPEATED SUCTION DUE TO INCREASED STIMULUS AND LEAKING WATER, BUT BESIDES THAT, NO PATIENT HARM/ADVERSE EVENT WAS REPORTED. THE OPERATOR OF THE DEVICE WAS THE PATIENT, AND THE EVENT TOOK PLACE IN THE PATIENTS¿ HOUSE AND THE PRODUCTS SHOWED DEFICIENCIES IMMEDIATELY UPON USE. THE CUSTOMER SAID THAT DEVICE PREPARATIONS WERE MADE ACCORDING TO THE INSTRUCTIONS. TWO DEVICES WERE INVOLVED REPRESENTING THE SAME PATIENT. THE SECOND REPORTED DEVICE WAS DOCUMENTED ON (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18546141 ↗
• MalfunctionOct 13, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TEST THE DEVICE CANNULA WAS FOUND TO BE DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595196 ↗
• MalfunctionOct 12, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT DURING PRE-TEST THE DEVICE CANNULA WAS FOUND TO BE DEFECTIVE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591610 ↗
• MalfunctionSep 20, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT MULTIPLE TRACHEOSTOMY FAILED TO INFLATE DURING PRE-TEST. MULTIPLE LOTS AFFECTED WITH 11 TRACHEOSTOMY IN TOTAL. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460021 ↗
• MalfunctionSep 20, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING PRE-TEST, USING 3ML OF WATER, THE CUFF WAS FOUND TO BE ASYMMETRICAL. WATER WAS TAKEN OUT OF THE CUFF AND REINSERTED WITH THE SAME ISSUE HAPPENING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15460018 ↗
• MalfunctionSep 15, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED DURING PRE-TEST, USING 3ML OF WATER, THE CUFF WAS FOUND TO BE ASYMMETRICAL. WATER WAS TAKEN OUT OF THE CUFF AND REINSERTED WITH THE SAME ISSUE HAPPENING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15433736 ↗
• MalfunctionSep 15, 2022Break; Tear, Rip or Hole in Device Packaging; Break; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE DEVICE WAS SENT TO CUSTOMER. WHEN IT WAS OPENED, IT WAS FOUND BROKEN. EYELET TEAR. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427015 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, USING 3ML OF WATER, THE CUFF WAS FOUND TO BE ASYMMETRICAL. WATER WAS TAKEN OUT OF THE CUFF AND REINSERTED WITH THE SAME ISSUE HAPPENING. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410871 ↗
• MalfunctionAug 18, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS NOTED TO BE LEAKING. THE PATIENT'S MOM WAS PUT 3.5 ML OF WATER IN THE CUFF AND HEARD A LEAK. WHEN SHE CHECKED AGAIN, THERE WAS 2.4 ML OF WATER IN THE CUFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8904575 ↗
• MalfunctionAug 18, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA FLEXTEND TTS PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE WAS NOTED TO BE LEAKING. THE PATIENT'S MOM WAS PUT 3.5 ML OF WATER IN THE CUFF AND HEARD A LEAK. WHEN SHE CHECKED AGAIN, THERE WAS 2.4 ML OF WATER IN THE CUFF. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 8904572 ↗
• MalfunctionApr 10, 2018Crack; Crack

  IT WAS REPORTED THAT THAT AFTER INSERTING A PORTEX® BIVONA® NEONATAL AND PEDIATRIC SILICONE TRACHEOSTOMY TUBE, THE CUFF CRACKED ON THE TIP OF THE TUBE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419536 ↗

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.