EOPA™ 77620 (UDI 20763000135663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20763000135663), received between May 25, 2023 and Sep 29, 2026 — classified as 2 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Fluid/Blood Leak

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50934037 ↗
• MalfunctionSep 16, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50791870 ↗
• InjurySep 15, 2026Fluid/Blood Leak; Material Puncture/Hole

  Medtronic received information that during use of a EOPA Arterial cannula, a small hole was identified in the wirewound section of the cannula, with an alleged leak. Blood was observed dripping from the operating table, and the hole was initially not visible because it was partially obscured by surgical drapes. Approximately 300 mL of blood loss was reported. The hole was patched with bone wax, and the operation was completed using the cannula. No blood transfusion was required. The patient was alive with no injury, and no patient harm was reported. Medtronic received additional information that the Leak was from the cannula, in the wirewound section, not near a connector. The cannula was not heated or cooled prior to use, and the damage was not in the location of the sutures.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 50770209 ↗
• MalfunctionApr 27, 2026Material Deformation

  IT WAS REPORTED THAT DURING ASSEMBLY OF THE EOPA ARTERIAL CANNULA, THE SCRUB NURSE INSERTED THE INTRODUCER INTO THE CANNULA BODY AND THE INTRODUCER TIP SNAPPED OFF. THE SNAPPED-OFF TIP WAS NOT DROPPED AND WAS ABLE TO BE PUT ASIDE. THE CANNULA WAS STILL USED BY THE SURGEON AND WAS USED WITHOUT ANY ISSUES. THERE WAS NO DAMAGE TO THE PACKAGING AND NO OBVIOUS DAMAGE TO THE CANNULA PRIOR TO THE INCIDENT. IT WAS REPORTED THAT THERE WAS NO IMPACT TO THE PATIENT AND THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24996057 ↗
• MalfunctionApr 2, 2026Mechanical Problem; Material Separation

  IT WAS REPORTED THAT DURING PREPARATION FOR USE OF A EOPA ARTERIAL CANNULA, THE PACKAGING WAS INTACT WITH NO DAMAGE NOTED AND THE CANNULA COMPONENTS WERE REMOVED FROM THE PACKAGING WITHOUT ISSUE. DURING INSERTION, THE INTRODUCER WAS REPORTED TO FEEL VERY LOOSE AND NOT SECURE. THE CANNULA WAS NOT USED AS A RESULT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24762402 ↗
• MalfunctionMay 14, 2025Contamination; Contamination

  IT WAS REPORTED THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, RED SPOTS WERE NOTICED ON THE DEVICE BEFORE OPENING THE PACKAGING. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO HOLE IN THE CANNULA, ONLY RED SPOTS. THE STERILE BARRIER WAS STILL SEALED WHEN THE FOREIGN MATERIAL (FM) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22016909 ↗
• MalfunctionDec 20, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE CRACKED WHEN THEY WERE INSERTING IT. THE EVENT TOOK PLACE DURING INSERTION AND BEFORE THE PATIENT WAS PUT ON BYPASS. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE DEVICE WAS NOT HEATED OR COOLED. THE DEVICE WAS STORED IN THE PERFUSION CONSUMABLES CABINET. THE CRACK HAPPENED MID-DISTANCE BETWEEN BOTH ENDS OF THE DEVICE. THEREFORE, THE CRACK WAS FAR AWAY OF THE SUTURING SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18365403 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THEY COULD NOT GET THE VENTED CAP ON THE CANNULA TO TIGHTEN AND IT LEAKED BLOOD DURING THE ENTIRE CASE. THEY ESTIMATE THAT PATIENT LOST 100ML OF BLOOD BECAUSE OF THIS LEAK, BUT CANNULA WAS NOT CHANGED OUT AND THE CASE WAS COMPLETED SUCCESSFULLY WITHOUT INJURY TO THE PATIENT OTHER THAN BLOOD LOSS.  ADDITIONAL INFORMATION: THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. IT WAS ASKED BUT UNKNOWN WHETHER A BLOOD TRANSFUSION WAS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245015 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE AT THE BEGINNING OF THE BYPASS, THE CUSTOMER REPORTED THE SURGEON COULD NOT USE THE EOPA ARTERIAL CANNULA GUIDE AS HE COULD NOT REMOVE THE CANNULAE CAPS, AS THEY WERE STUCK ON. DEVICE WAS REPLACED TO COMPLETE THE CASE. THERE WAS NO ADVERSE EFFECT TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17004055 ↗
• MalfunctionMay 25, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE THE CUSTOMER NOTICED THAT THE CANNULA WAS BENT AND CRACKED. THE CANNULA WAS NOT USED AND NOT REPLACED FOR THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002029 ↗

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-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-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-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