Bio-Medicus® 96820-008Recalls & reported problems
Medtronic, Inc. · CANNULA 96820-008 BIO-MED ART 8FR EA 17L · Class 2
All models of Bio-Medicus (59)
Data updated Oct 16, 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 00613994530707), received between Jan 30, 2020 and Jan 30, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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.
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 30, 2020Material Split, Cut or Torn; Material Split, Cut or Torn
MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A BIO-MEDICUS ONE-PIECE FEMORAL ARTERIAL CANNULA, IT WAS NOTED THAT THERE WAS BLOOD LEAKING FROM THE MIDDLE PART OF THE CANNULA THAT WAS INSERTED INTO THE PATIENT. IT WAS ASKED BUT UNKNOWN HOW MUCH BLOOD LEAKED. A TRANSFUSION WAS NOT REQUIRED. THE CANNULA WAS REMOVED AND IT WAS SEEN THAT IT WAS RIPPED FROM THE WIRE WINDING MIDDLE PART. NO DAMAGE WAS OBSERVED TO THE CANNULA PRIOR TO USE. THE CUSTOMER STATED THE DAMAGE TO THE CANNULA WAS NOT CAUSED BY THE SUTURES. THE CANNULA WAS REPLACED TO COMPLETE THE CASE. THERE WERE NO PATIENT ADVERSE EFFECTS AS A RESULT OF THE REPORTED ISSUE.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9646303 ↗
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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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