Bivona 67PFPS45Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10351688518552), received between May 8, 2019 and Apr 14, 2023 — classified as 3 injuries, 12 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (6 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-2612-2024 · 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.

• InjuryApr 14, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT ON ROUTINE 4 HOURLY DEFLATING AND REFLATING BALLOON WITH 4MLS OF WATER, IT'S BEEN REPORTED THAT WITHIN A MATTER OF 10 MINUTES THE BALLOON HAD ONLY 1ML IN BALLOON. THE BALLOON WAS DEFLATING INTERNALLY, CHECKED TUBED AND FOUND IT HAD RUPTURED. THIS TUBE WAS ON THE 2ND USE. NO INJURY OCCURRED; HOWEVER AN EMERGENCY TRACH CHANGE WAS CARRIED OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16743404 ↗
• MalfunctionMar 28, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT WHEN THE SCRUB INFLATED THE CUFF TO VERIFY INTEGRITY. IT WAS NOTED THAT ONLY ONE SIDE OF THE TRACH CUFF INFLATED, THUS THIS TRACH WAS DEFECTIVE. ANOTHER TRACH OF THE SAME SIZE WAS OBTAINED. THERE HAS BEEN NO REPORT OF OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16630176 ↗
• MalfunctionOct 12, 2022Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT THE TRACH NEVER MADE IT THROUGH FIRST PROCESS. THE TECHNICIAN NOTICED DURING PRE-STEAM THAT THE SILICONE ON THE NECK FLANGE BEGAN FLAKING AND PEELING OFF. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591302 ↗
• MalfunctionSep 20, 2022Physical Resistance/Sticking; Physical Resistance/Sticking

  IT WAS REPORTED THAT DURING A HOSPITAL PRE-TEST OF THE TRACHEOSTOMY TUBE, THE PLASTIC SHEATH ON THE OBTURATOR WAS MOVING BACKWARDS AND FORWARDS MAKING IT VERY DIFFICULT TO PULL THE OBTURATOR AWAY FROM THE TUBE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15456264 ↗
• MalfunctionSep 13, 2022Defective Component; Defective Component

  IT WAS REPORTED THAT DURING THE PRE-TEST, THE CUFF INFLATED ASYMMETRICALLY. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15410269 ↗
• MalfunctionSep 13, 2022Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT DURING PRE-TEST, THE CUFF WAS INFLATING ASYMMETRICALLY. NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15409662 ↗
• MalfunctionAug 23, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280030 ↗
• MalfunctionAug 23, 2022Leak/Splash; Leak/Splash

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15280010 ↗
• InjuryApr 25, 2022Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED THAT AFTER BEING USED 4 OR 5 TIMES, THE BALLOON ON THE TRACHEOSTOMY TUBE IS NO LONGER INFLATING. AN EMERGENCY TRACHEOSTOMY CHANGE WAS CARRIED OUT TO RESOLVE THE ISSUE. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14193844 ↗
• MalfunctionFeb 23, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THE DEVICE'S CUFF WAS LEAKING. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13583242 ↗
• MalfunctionSep 21, 2021Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND PLUS WAS SLIGHTLY LONGER THAN THE REGULAR PEDS TRACH AND THERE WAS AN ISSUE WITH PATIENT NOT TOLERATING THEM. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12509626 ↗
• MalfunctionJan 13, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THE DEVICE CUFF WOULD NOT INFLATE. NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 11167332 ↗
• MalfunctionJan 13, 2021Inflation Problem; Inflation Problem

  INVESTIGATION COMPLETED AND SUMMARY IN H 10.

  Patient problems: No Patient Involvement

  MAUDE report 11167248 ↗
• MalfunctionOct 24, 2019Crack; Fracture; Crack; Fracture

  INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL TRACHEOSTOMY WAS IN USE, DEVICE CRACKED AT THE HUB. NO ADVERSE EFFECTS REPORTED.

  Patient problems: No Information

  MAUDE report 9235375 ↗
• InjuryMay 8, 2019Difficult to Remove; Mechanical Jam; Difficult to Remove; Mechanical Jam

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE WAS PLACED IN A PATIENT AFTER A ROUTINE TRACHEOSTOMY (TRACH) TUBE CHANGE. WHEN THE TUBE WAS PLACED, IT WAS REPORTED THAT "THE SHEATH OVER THE OBTURATOR MOVED UP AND JAMMED SO THAT THE OBTURATOR WAS NOT ABLE TO BE TAKEN OUT". SUBSEQUENTLY, THE TRACH HAD TO BE TAKEN OUT AND THE OLD DEVICE WAS PUT BACK INTO THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS. INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND TTS PEDIATRIC TRACHEOSTOMY TUBE WAS PLACED IN A PATIENT AFTER A ROUTINE TRACHEOSTOMY (TRACH) TUBE CHANGE. WHEN THE TUBE WAS PLACED, IT WAS REPORTED THAT "THE SHEATH OVER THE OBTURATOR MOVED UP AND JAMMED SO THAT THE OBTURATOR WAS NOT ABLE TO BE TAKEN OUT". SUBSEQUENTLY, THE TRACH HAD TO BE TAKEN OUT AND THE OLD DEVICE WAS PUT BACK INTO THE PATIENT. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8591091 ↗

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.