EOPA™ 77524Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000135564), received between Sep 20, 2024 and Apr 28, 2026 — classified as 5 malfunctions.

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

1 FDA recall record name this device's identifier, 1 still open.

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 28, 2026Contamination; Obstruction of Flow

  IT WAS REPORTED THAT, DURING USE OF AN EOPA ARTERIAL CANNULA SEVERAL SPECTACLES OF WHITE MATERIAL WERE NOTICED WITHIN THE CANNULA, WHICH THE CUSTOMER SUSPECTS TO BE FIBRIN. THE REST OF THE BYPASS TUBING WAS CLEAR. THIS WAS NOTICED PRIOR TO ADMINISTRATION OF PROTAMINE. THE CANNULA WAS NOT REPLACED AND THE CASE WAS COMPLETED AS NORMAL. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25014477 ↗
• MalfunctionMar 6, 2026Mechanical Problem

  IT WAS REPORTED THAT PRIOR TO USE, THE EOPA ARTERIAL CANNULA WAS ALLEGED TO HAVE A PRODUCT ISSUE, SPECIFICALLY THAT THE WHITE INSET WAS NOT SITTING RIGHT, WAS NOT HOLDING IN PLACE PROPERLY, AND WOULD SIT OUT TOO FAR IF PUSHED IN FURTHER. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528904 ↗
• MalfunctionJun 13, 2025Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA EXHIBITED SEVERAL ISSUES PRIOR TO USE. THE WHITE CONNECTOR AT THE DISTAL SIDE OF THE INTRODUCER ABOVE THE RED HEMOSTASIS CAP WAS ALLEGED TO SLIDE VERY EASILY INTO THE HOLE OF THE RED HEMOSTASIS CAP. THE INTRODUCER TIP WAS NOTED TO EXIT THE CANNULA AT A LONGER LENGTH THAN USUAL, WHICH WAS CONSIDERED TO MAKE INSERTION OF THE CANNULA INTO THE AORTA DANGEROUS. IT WAS FURTHER REPORTED THAT THE HOLE OF THE RED HEMOSTASIS CAP ENLARGES WITH THE CANNULA FRENCH SIZE BUT NOT THE CONNECTOR, CAUSING THE INTRODUCER TO SLIDE IN MORE THAN INTENDED. THESE ISSUES WERE OBSERVED ONLY WITH THE 24FR CANNULA AND NOT WITH THE 15FR, 17FR, OR 22FR ARTERIAL EOPA CANNULAE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22201321 ↗
• MalfunctionOct 1, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT BEFORE OPENING THE PACKAGING THE CANNULA WAS FLATTENED. THERE WAS NO DAMAGE TO THE PACKAGING AND NO OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE DAMAGED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20342030 ↗
• MalfunctionSep 20, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE WAS BENT/KINKED DURING THE PROCEDURE. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20266728 ↗

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-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-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-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-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-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