Skip to content

Bivona 65SP050Recalls & 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
1
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15021312000320), received between Dec 21, 2020 and Dec 21, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation Problem” (1 report).

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

Device problems

  • Inflation Problem1

Patient problems

  • No Information1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 21, 2020Inflation Problem; Inflation Problem

    INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH ONE CC OF AIR WAS ABLE TO BE PUT INTO THE PILOT BALLOON USING A SYRINGE BEFORE THE SYRINGE "VIGOROUSLY CAME OFF FROM IT". THERE WERE NO REPORTED ADVERSE EVENTS.

    Patient problems: No Information

    MAUDE report 11047981 ↗

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.