EOPA™ 77522 (UDI 20613994888826)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20613994888826), received between Oct 26, 2023 and Oct 26, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Separation” (1 report).

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.

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.

• MalfunctionOct 26, 2023Material Separation; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS EOPA ARTERIAL CANNULA HAD A LOOSE COMPONENT. THE CUSTOMER STATED THAT THE BODY OF THE CANNULA BECAME LOOSE FROM THE CONNECTOR. THE CUSTOMER STATED THAT THEY WERE FORTUNATE THAT THEY WERE OFF BYPASS BUT STILL VERY CONCERNING IF THIS IS A LOT ISSUE AS WELL AS THE POTENTIAL INTRODUCTION OF AIR INTO THE AORTA. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WERE NO ADVERSE PATIENT EVENTS. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CONNECTOR BECAME DISCONNECTED FROM THE CANNULA BODY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18010671 ↗

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-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