Bio-Medicus™ CB96825-008Recalls & reported problems
Medtronic, Inc. · CANNULA CB96825-008 BIO-MEDICUS 8FR · Class 2
- 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 00763000193539), received between Jan 13, 2026 and Jan 13, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Deformation” (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.
Reports received per month
Most reported problems
Device problems
- Material Deformation1
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.
MalfunctionJan 13, 2026Material Deformation
IT WAS REPORTED THAT DURING USE OF A BIO-MEDICUS ONE PIECE FEMORAL VENOUS CANNULA THE OBTURATOR WAS DAMAGED/DEFORMED. IT WAS STATED THAT THE OBTURATOR WAS WARPED. THERE WAS NO DAMAGE TO THE PACKAGING. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24051410 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.