EOPA 3D® 78220 (UDI 20763000135694)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20763000135694), received between May 25, 2023 and Sep 22, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857341 ↗
• MalfunctionJul 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS CANNULA THE CUSTOMER NOTED THAT THE CANNULA HAD A SIGNIFICANT CRIMP. THE ISSUE WAS NOTED BEFORE THE CANNULA WAS HANDED UP TO THE STERILE FIELD. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245586 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THE 78220 EOPA 3D CANNULAE, THE PHYSICIAN HAS BEEN EXPERIENCING THE RED CAP POPPING OFF DURING INSERTION. THEY STATED THAT IT HAS BEEN HAPPENING IN BOTH SIZES OF THIS 3D EOPA, INCLUDING THE 22FR. THE SURGEON AT THIS FACILITY HAS PULLED ALL CANNULAE FROM THE SAME LOT, THAT THEY HAVE ON THEIR SHELF, AND REFUSED TO USE THEM. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECT OCCURRED. ADDITIONAL INFORMATION FROM THE SALES REP: FOUR UNOPENED CANNULA WERE RETURNED FOR THIS EVENT. THE HCP REPORTED THAT THE CAP WAS NOT DAMAGED IN ANY WAY OR LOOSE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002252 ↗