Bio-Medicus® 96820-012Recalls & reported problems
Medtronic, Inc. · CANNULA 96820-012 BIO-MED ART 12F 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 00613994530721), received between Jul 17, 2019 and Jul 17, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
- Insufficient Device Problem Information1
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.
MalfunctionJul 17, 2019Insufficient Device Problem Information; Insufficient Device Problem Information
MEDTRONIC RECEIVED INFORMATION THAT DURING USE, THE CUSTOMER REPORTED A 12 FR BIO-MEDICUS PEDIATRIC ARTERIAL CANNULA AND OBTURATOR THAT HAD A HOLE IN THE WIRE PORTION OF THE CANNULA. THE PRODUCT WAS REPLACED. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. THE PATIENT LOST APPROXIMATELY 25ML BLOOD, NO TRANSFUSION REQUIRED. NO DAMAGE TO THE PACKAGING NOTED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER: WE HAVE A 12 FR BIO-MEDICUS PEDIATRIC ARTERIAL CANNULA AND OBTURATOR THAT HAS A HOLE IN THE WIRE PORTION OF THE CANNULA. THIS WAS FOUND AFTER THE CANNULA WAS IN AND THE OBTURATOR REMOVED. ON THE CANNULA, THERE IS A PLACE WHERE THE WIRE PORTION HAS BEEN CLAMPED TO ISOLATE THE LEAK FROM THE BABY. THE HOLE WILL THEREFORE BE JUST ABOVE, OR TOWARD THE CONNECTOR PORTION OF THIS CANNULA. THE CASE WAS FOR DR. WELKE, A PARTIAL ANOMALOUS PULMONARY VENOUS RETURN PATIENT. THIS CAUSED A PATIENT CARE ISSUE AND NECESSITATED CHANGING OUT THE CANNULA AFTER IT WAS INSERTED INTO THE AORTA AND ATTACHED TO THE HEART LUNG MACHINE. NO NEGATIVE PATIENT OUTCOME IS APPARENT FROM THIS INCIDENT AT THIS TIME.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 8797550 ↗
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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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