Bio-Medicus™ CB96570-019Recalls & reported problems
Medtronic, Inc. · CANN CB96570-019 BIO-MEDICUS 19FR · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000193379), received between May 12, 2023 and May 12, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (1 report).
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.
Most reported problems
Device problems
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 12, 2023Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A CB96570-019 BIO-MEDICUS FEMORAL CANNULA, THE PHYSICIAN TRIED TO PUT THE CANNULA/ INTRODUCER INTO THE VESSEL AND FELT THAT IT WAS NOT ADVANCING AS IT SHOULD. THEY WITHDREW IT FROM THE VESSEL AND LOOKED AT IT CLOSELY. THEY FELT THAT IT WAS DEFECTIVE DUE TO THE CANNULA TIP BEING DAMAGED. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT IMPACT ASSOC IATED WITH THIS EVENT. ADDITIONAL INFORMATION: THE CUSTOMER REPORTED THAT THE CANNULA AND INTRODUCER WERE ASSEMBLED PRIOR TO USE WITHOUT NOTICING ANY DEFECTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16918944 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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