EOPA 3D® 78220 (UDI 20763000946849)Recalls & reported problems
Medtronic, Inc. · CANNULA 78220 EOPA 3D 20FR VNTED 10P 17L · Class 2
All models of EOPA 3D (8)
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 20763000946849), received between Apr 25, 2025 and Apr 25, 2025 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (2 reports).
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
- Contamination2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 25, 2025Contamination; Contamination
(PLI10) IT WAS REPORTED THAT CONDENSATION WAS FOUND IN THE PACKAGING OF THE EOPA 3D ARTERIAL CANNULA, RENDERING IT NON-STERILE AND UNUSABLE. (PLI20) ADDITIONALLY, FOREIGN MATERIAL WAS PRESENT IN ANOTHER CANNULA FROM THE SAME BATCH. THE CUSTOMER NOTICED THESE ISSUES UPON OPENING THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907741 ↗MalfunctionApr 25, 2025Contamination; Contamination
(PLI10) IT WAS REPORTED THAT CONDENSATION WAS FOUND IN THE PACKAGING OF THE EOPA 3D ARTERIAL CANNULA, RENDERING IT NON-STERILE AND UNUSABLE. (PLI20) ADDITIONALLY, FOREIGN MATERIAL WAS PRESENT IN ANOTHER CANNULA FROM THE SAME BATCH. THE CUSTOMER NOTICED THESE ISSUES UPON OPENING THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21907731 ↗
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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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