Bivona 65SP035Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15021312000290), received between Feb 17, 2017 and Sep 23, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Air Leak” (2 reports).

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

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-2605-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2021Inflation Problem; Pressure Problem; Inflation Problem; Pressure Problem

  INFORMATION WAS RECEIVED INDICATING THAT WHILE IN USE OF A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED AIRE-CUF, THE CUSTOMER HAD TO KEEP INFLATING THE CUFF EVERY TWO HOURS. OTHERWISE, AIR PRESSURE OF THE CUFF LOWERED. NO PATIENT CONSEQUENCES WERE REPORTED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12521327 ↗
• InjuryJan 4, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX® BIVONA® AIRE-CUF® TRACHEOSTOMY TUBE AIR PRESSURE LOWERED. SUBSEQUENTLY, A TRACHEOSTOMY (TRACH) TUBE CHANGE OUT WAS PERFORMED WITH NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8219917 ↗
• MalfunctionAug 7, 2017Break; Break

  IT WAS REPORTED THAT A BREAK WAS FOUND IN THE FLANGE OF A PORTEX® BIVONA® AIRE-CUF® PEDIATRIC TRACHEOSTOMY TUBE. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6770911 ↗
• MalfunctionMar 28, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT A PORTEX® BIVONA® AIRE-CUF® NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE AIR IN THE CUFF DECREASED TO HALF-CAPACITY 6 HOURS AFTER INITIAL USE WITH A PATIENT. THE ISSUE WAS OBSERVED BY MEDICAL PERSONNEL. IT WAS UNKNOWN IF THE TUBE HAD BEEN CHECKED PRIOR TO USE. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A NEW ONE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6439277 ↗
• MalfunctionFeb 17, 2017Air Leak; Air Leak

  IT WAS REPORTED THAT THE BIVONA® AIRE-CUF® PEDIATRIC STRAIGHT NECK FLANGE TRACHEOSTOMY TUBE HAD A LEAK IN THE DEVICE CUFF. THE EVENT WAS OBSERVED SPONTANEOUSLY BY A MEDICAL PROFESSIONAL AND THE DEVICE WAS REPLACED AFTER DISCOVERY. ACCORDING TO THE REPORTER, THE DEVICE WAS IN PATIENT USE FROM (B)(6) 2017. THE REPORTED EVENT OCCURRED DURING THE INITIAL USE OF THE TRACHEOSTOMY TUBE AND THE DEVICE CUFF WAS TESTED PRIOR TO PATIENT USE. IT WAS REPORTED THAT THE EVENT WAS RESOLVED AND THAT NO PATIENT INJURY OCCURRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6341315 ↗