Bio-Medicus™ CB96670-019 (UDI 00763000193515)Recalls & reported problems
Medtronic, Inc. · CANN CB96670-019 BIO-MEDICUS 19FR · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000193515), received between Apr 4, 2022 and Sep 2, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Crack” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Crack1
- Fluid/Blood Leak1
- Mechanical Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2025Mechanical Problem; Mechanical Problem
MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A BIO-MEDICUS CANNULA, IT WAS REPORTED THAT UPON OPENING THE PACKAGING FOR USE, THE TUBE INNER CORE WAS NOT COMPATIBLE WITH THE TUBE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22935754 ↗MalfunctionApr 4, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS CANNULA, THE CUSTOMER OBSERVED A CRACK ON THE CANNULA BODY AND A LEAK WAS OBSERVED FROM THE CANNULA. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED STATES THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES.
Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions
MAUDE report 13994589 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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