EOPA 3D® 78322 (UDI 20763000135526)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000135526), received between Aug 30, 2022 and Aug 30, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryAug 30, 2022Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA CANNULA, IT WAS REPORTED THAT A HOLE WAS OBSERVED IN THE CANNULA. THE CUSTOMER STATED THAT THERE WAS A SIGNIFICANT LEAK FROM THE CANNULA AND THE SURGEON HAD TO MAKE A "PLASTIE" OF THE CANNULA. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADDITIONAL PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT IT WAS DIFFICULT TO QUANTIFY THE AMOUNT OF BLOOD LOST DUE TO THE LEAK. A TRANSFUSION WAS NOT NECESSARY. THERE WAS NO AIR INTRODUCED INTO THE SYSTEM/CIRCUIT DUE TO THE HOLE. THE CANNULA WAS NOT WARMED OR COOLED BEFORE USE. THERE WAS DAMAGE AT THE LOCATION OF THE SUTURES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15318377 ↗