EOPA™ 77520 (UDI 20763000135540)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000135540), received between Apr 18, 2024 and Sep 30, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 reports).

6 other recalls cover devices cleared under the same FDA submission (K031037); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 30, 2024Mechanical Problem; Misassembled During Installation; Mechanical Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER FULLY ASSEMBLED THE DEVICE AND NOTICED THAT THE WHITE INTRODUCER DID NOT PROTRUDE FROM THE CANNULA BODY AS NORMAL. THE CUSTOMER FELT THAT IT WOULD CAUSE AN ISSUE AT CANNULATION. THE PROCEDURE COMMENCED WITH ONLY A FEW MINUTES OF DELAY BUT THERE WAS NO PATIENT IMPACT AS A RESULT OF THE DELAY. THE CUSTOMER SUSPECTED THAT THE CANNULA BODY WAS TOO LONG OR THE WHITE INTRODUCER WAS TOO SHORT FROM MANUFACTURING. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20332227 ↗
• MalfunctionSep 9, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE WAS BENT. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20167899 ↗
• MalfunctionMay 20, 2024Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS EVIDENCE OF DAMAGE TO THE DEVICE, WITH PINCHING VISIBLE IN THE MIDDLE THIRD OF THE RINGED CANNULA BODY, AND THIS PREVENTS THE PASSAGE OF THE GUIDE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19351644 ↗
• MalfunctionApr 18, 2024Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS EOPA ARTERIAL CANNULA HAD A CONNECTION THAT WAS NOT HEAT-BONDED TO THE DEVICE, UNLIKE OTHER CANNULAE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19132534 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K031037. One submission often covers many models, so check the product and lot details in each record.

• Z-2808-2026 · Jun 24, 2026 · Open, Classified
  EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77622
• Z-2806-2026 · Jun 24, 2026 · Open, Classified
  EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
• Z-2807-2026 · Jun 24, 2026 · Open, Classified
  EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77522
• Z-2809-2026 · Jun 24, 2026 · Open, Classified
  EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77722
• Z-0985-2025 · Dec 12, 2024 · Open, Classified
  EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
• Z-2420-2015 · Jul 24, 2015 · Terminated
  Medtronic EOPA Arterial Cannula, Model # 77620. Lot: 2015060544 intended to deliver oxygenated blood to the heart during cardiopulmonary bypass procedures for up to 6 hours in du