Bivona 67PFPS60Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10351688518583), received between Jul 5, 2018 and Jul 27, 2026 — classified as 7 injuries, 27 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (18 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-2612-2024 · 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.

• MalfunctionJul 27, 2026Infusion or Flow Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50017257 ↗
• MalfunctionJul 27, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50016806 ↗
• MalfunctionAug 7, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH'S BALLOON DID NOT INFLATE PROPERLY. THERE WAS NO REPORTED PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22739571 ↗
• MalfunctionJul 22, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS STATED THAT FOAM GAUZE FROM UNDER TRACH TIE AND TRACH FLANGE BROKE. THE EVENT OCCURRED WHILE IN USE WITH PATIENT, AND IT HAPPENED IN BED. OPERATOR OF THE DEVICE WAS THE NURSE. THE ISSUE WAS RESOLVED BY CHANGING THE TRACH TUBE TO NEW ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571820 ↗
• MalfunctionJul 16, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ONE OF THE TRACHEOSTOMY TUBES CAME WITH A DEFECTIVE BALLOON THAT WOULD NOT INFLATE. THIS WAS DISCOVERED OUT OF BOX. NO MEDICAL INTERVENTION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22519580 ↗
• MalfunctionJun 19, 2025Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THERE WAS A TEAR IN FLANGE FOUND DURING TRACH CARE. THE TRACH WAS NEW, AND HAD NOT BEEN THROUGH IN-HOUSE STERILIZATION YET. EVENT OCCURRED DURING TRACH CARE AT (B)(6) IN USA, AND THE OPERATOR OF THE DEVICE WAS AN RT. THE ISSUE WAS RESOLVED BY CHANGING A NEW TRACH. PATIENT INITIAL IS (B)(6), HE IS A 22-YEAR-OLD MALE FILIPINO, ASIAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292989 ↗
• MalfunctionApr 1, 2025Material Puncture/Hole; Gas/Air Leak; Material Puncture/Hole; Gas/Air Leak

  IT WAS REPORTED THAT THE CUSTOMER CALLED TO INFORM THE WRITER THAT ONE OF THE TRACH'S HAD A HOLE, AND THEY WERE NOT ABLE TO BLOW UP THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739700 ↗
• MalfunctionJan 14, 2025Inflation Problem; Unintended Deflation; Inflation Problem; Unintended Deflation

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. NO MEDICAL INTERVENTION REQUIRED. THERE WAS A PATIENT INVOLVEMENT, AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21147581 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113244 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21113129 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112831 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112773 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112428 ↗
• MalfunctionJan 9, 2025Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING PROPERLY OR DID NOT STAY INFLATED. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21112075 ↗
• MalfunctionJul 16, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT THE DEVICE WOULD NOT FULLY INFLATE. THERE WAS NO PATIENT INVOLVEMENT OR PATIENT HARM/ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752459 ↗
• MalfunctionJul 16, 2024Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT INFLATE PROPERLY, THE TUBE WILL NOT INFLATE THE BALLOON ALL THE WAY ROUND. PATIENT COUGHED SOME SPITTING AND SATS DROPPING FELL ON DEVICE, AND DEVICE WAS REMOVED. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT HARM OR ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19752273 ↗
• MalfunctionJul 12, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE DOES NOT INFLATING PROPERLY. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19734218 ↗
• MalfunctionMay 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE WON¿T INFLATE. THIS HAS HAPPENED NUMEROUS TIMES BEFORE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331141 ↗
• MalfunctionMay 16, 2024Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE TRACH TUBE WON¿T INFLATE. THIS HAS HAPPENED NUMEROUS TIMES BEFORE. THERE WAS PATIENT INVOLVEMENT AND NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19331110 ↗
• MalfunctionMay 3, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE. THE CUSTOMER STATED THAT THE PRODUCT WAS DEFECTIVE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861469 ↗
• MalfunctionMay 3, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFFS DID NOT INFLATE. THE CUSTOMER REPORTED THEY ARE DEFECTIVE. THERE WERE NO REPORTS OF PATIENT HARM OR IMPACT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16861401 ↗
• MalfunctionFeb 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE DEVICE WOULD NOT INFLATE. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT, NO OBSERVABLE CLINICAL SYMPTOMS, OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 16436085 ↗
• MalfunctionJan 24, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE BALLOON IS NOT INFLATING. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER NO FURTHER INFORMATION WAS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16235217 ↗
• MalfunctionSep 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TRACHEOSTOMY WAS LEAKING. THE PATIENT FOUND OUT PRIOR THE DEVICE USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459436 ↗
• MalfunctionSep 20, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT TRACHEOSTOMY WAS LEAKING. THE PATIENT FOUND OUT PRIOR THE DEVICE USE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459416 ↗

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.