EOPA™ 77722 (UDI 20643169340484)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169340484), received between Jan 24, 2020 and Jan 24, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionJan 24, 2020Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS NOTED THAT THERE WAS A PINHOLE LEAK FROM THE CANNULA THROUGHOUT THE CASE. THE CUSTOMER PUT A TOWEL OVER THE CANNULA TO COMPLETE THE CASE. THE PRODUCT WAS USED TO COMPLETE THE CASE. PATIENT LOST 100ML OF BLOOD A TRANSFUSION WAS NOT REQUIRED.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 9626747 ↗

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-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-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-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