EOPA™ CB77420Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000238391), received between Nov 4, 2022 and Nov 4, 2022 — classified as 1 malfunction.

The most frequently reported specific device problem is “Crack” (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.

• MalfunctionNov 4, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA CANNULA, THE CUSTOMER REPORTED THAT BLEEDING WAS NOTICED FROM THE DEVICE. UPON FURTHER INSPECTION, A CRACK WAS OBSERVED ON THE LUER CONNECTOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. IT WAS ALSO REPORTED THAT THE PATIENT HAD TO BE EMERGENTLY SEPARATED FROM BYPASS TWICE TO REMOVE THE CRACKED PORTION OF THE CANNULA. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE, AND WAS STORED AT ROOM AIR (APPROX 20C) AND USED AT NORMOTHERMIA WITH PATIENT (37C). THE DEFECT IS IN THE LUER CONNECTION ON CONNECTOR OF CANNULA. THERE WAS MINIMAL BLOOD LOSS, SLOW LEAK FROM CRACK IN LUER. NO TRANSFUSION WAS REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15725424 ↗

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-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-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