Bio-Medicus® 96830-008Recalls & reported problems
Medtronic, Inc. · CANNULA 96830-008 BIO-MED VEN 8FR EA 17L · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994530783), received between Oct 22, 2018 and Oct 22, 2018 — classified as 1 injury.
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. How this data works · Data updated Oct 13, 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.
InjuryOct 22, 2018Material Split, Cut or Torn; Material Split, Cut or Torn
MEDTRONIC RECEIVED INFORMATION THAT DURING CANNULATION USING A BIO-MEDICUS PEDIATRIC VENOUS CANNULA, AIR WAS ENTERING INTO THE ECMO LINE/CIRCUIT, GENERATING AT WHAT THE CUSTOMER BELIEVED WAS THE CANNULA. THE PATIENT HAD TO COME OFF BYPASS/ECMO TO CHANGE THE CANNULA OUT. DURING THAT TIME THEY WERE OFF BYPASS, THE PATIENT RECEIVED CHEST COMPRESSIONS, SEVERAL ROUNDS OF EPINEPHRINE AND CALCIUM GLUCONATE TO MAINTAIN PRESSURE. ONCE THE CANNULA WAS REPLACED, THERE WERE NO FURTHER ISSUES WITH AIR ENTERING THE CIRCUIT AND THE ECMO RUN CONTINUED UNEVENTFULLY. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7989199 ↗
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- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
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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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