Bivona 65SP040Recalls & 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
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15021312000306), received between May 26, 2021 and May 21, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (3 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.
Reports received per month
Recalls naming this device
- 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
- Break3
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 21, 2025Break; Break
IT WAS REPORTED THAT THE FLANGE IS BROKEN AT THE BASE. PER REPORTER, THE EVENT OCCURRED DURING PATIENT USE. THE OUTCOME OF THE REPORTED ISSUE WAS NOT INDICATED, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 22062593 ↗MalfunctionFeb 9, 2022Break; Break
IT WAS REPORTED THAT THREE DAYS AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER NOTICED THERE WAS AN ALARM SOUNDING FROM THE CUFF PRESSURE GAUGE. THEY CHECKED THE PRODUCT AND THE ONE-WAY VALVE WAS FOUND DAMAGED. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13500078 ↗MalfunctionFeb 9, 2022Break; Break
IT WAS REPORTED THAT TEN DAYS AFTER STARTING TO USE THE PRODUCT, THE CUSTOMER FOUND A CRACK IN THE FLANGE OF THE TRACHEOSTOMY TUBE. THERE WAS NO PATIENT INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13499174 ↗MalfunctionMay 26, 2021Material Split, Cut or Torn; Material Split, Cut or Torn
INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL TRACH'S FLANGE WAS TORN FROM THE BASE. A TRACH CHANGE WAS PERFORMED BY MEDICAL PROFESSIONALS TO RESOLVE THE ISSUE. BEFORE AND AFTER THE REPLACEMENT, THERE WAS NO PARTICULAR CHANGE IN RESPIRATORY STATUS OF THE PATIENT. THERE WAS NO PATIENT INJURY. THERE WERE NO REPORTED ADVERSE EVENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11886438 ↗
Other Tube tracheostomy and tube cuff devices
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- Shiley 6CN75HCovidien LP · Tube tracheostomy and tube cuff1 recall3 deaths240 reports
- Shiley 7CN80RCovidien LP · Tube tracheostomy and tube cuff2 recalls148 reports
- Bivona 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 670180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall140 reports
- Bivona 670170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall10 deaths132 reports
- Shiley 6CN75RCovidien LP · Tube tracheostomy and tube cuff1 recall1 death121 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.