Skip to content

Bivona 65P030Recalls & reported problems

Icu Medical, Inc. · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
2
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312005950), received between Jul 23, 2021 and May 3, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (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-2604-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Device problems

  • Contamination of Device Ingredient or Reagent2
  • Fumes or Vapors1

Patient problems

  • Insufficient Information1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 3, 2023Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

    IT WAS REPORTED THAT THE CUFF HAD OIL POLLUTION ON INNER BOXES. NO PATIENT INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16860729 ↗
  • MalfunctionJul 23, 2021Fumes or Vapors; Contamination of Device Ingredient or Reagent; Fumes or Vapors; Contamination of Device Ingredient or Reagent

    INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED AIRE-CUF HAS OIL POLLUTION ON INNER BOXES. PHOTOS ATTACHED. NO ADVERSE PATIENT EVENTS REPORTED.

    Patient problems: Insufficient Information

    MAUDE report 12221006 ↗

Other Tube tracheostomy and tube cuff devices

All Tube tracheostomy and tube cuff devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.