EOPA™ 77424Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 20763000135649), received between May 25, 2023 and Sep 29, 2026 — classified as 17 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (7 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50940762 ↗
• MalfunctionNov 27, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA WAS IDENTIFIED AS DEFECTIVE PRIOR TO USE, WITH THE TIP OF THE CANNULA CRIMPED AND A RAISED AREA PRESENT. THIS HAD THE POTENTIAL TO TEAR THE AORTA AS IT WAS PASSED THROUGH THE SMALL NICKED INCISION USED TO CANNULATE THE AORTA. WHEN CANNULATING, THE INCISION IS MADE SLIGHTLY SMALLER THAN THE DIAMETER OF THE CANNULA. THERE IS A DILATOR INSIDE THE CANNULA PROTRUDING THROUGH THE END OF THE CANNULA. THIS HELPS TO STRETCH THE TISSUE TO HAVE A SNUG FIT AROUND THE CANNULA. IF BOTH THE DILATOR AND CANNULA ARE NOT SMOOTH, THERE IS TRAUMA TO THE AORTA. THERE WAS NO DAMAGE TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23663904 ↗
• MalfunctionJul 31, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING CANNULATION WITH THE EOPA ARTERIAL CANNULA, THE CANNULA KINKED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22674282 ↗
• MalfunctionJul 17, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT AN ALLEGED PRODUCT ISSUE OCCURRED WITH THE EOPA ARTERIAL CANNULA DURING A PROCEDURE. THE CANNULA WAS KINKED. NO OTHER ISSUES WERE OBSERVED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PUMP WAS ON THE RIGHT SIDE OF THE PATIENT. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22529795 ↗
• MalfunctionDec 5, 2024Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA WAS RUPTURED. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WAS DETECTED PRE-OPERATIVELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20852110 ↗
• MalfunctionApr 17, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A SMALL AMOUNT OF PATIENT BLOOD LOSS FROM THE DEVICE DURING CANNULATION. THERE WAS APPROXIMATELY 100-200MLS OF BLOOD LOSS. THE CUSTOMER STATED THAT THE WHITE STYLUS APPEARED TOO SMALL/NARROW FOR THE CANNULA WHICH RESULTED IN A MESSY CANNULATION. THE CUSTOMER STATED THAT THEY ARE AN EXPERIENCED CANNULATOR. THERE WAS NO TRANSFUSION REQUIRED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO CANNULATION. THE PATIENT WAS ALREADY HEPARINISED, THEREFORE, THE BLOOD WAS RETURNED TO THE EXTRACORPOREAL BYPASS CIRCUIT AND THEN TO THE PATIENT CIRCULATION ONCE THE BYPASS CIRCUIT WAS CONNECTED TO THE AORTIC CANNULA.THE DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19123139 ↗
• MalfunctionFeb 8, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18666281 ↗
• MalfunctionFeb 6, 2024Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER PLACED THE DEVICE, THEN IMMEDIATELY REMOVED IT ASKING FOR ANOTHER ONE. THE CUSTOMER STATED THAT IT WAS CLEARLY FAULTY, AS THE STYLET WAS LOOSE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18649123 ↗
• MalfunctionJan 16, 2024Fluid/Blood Leak; Misassembled During Installation; Fluid/Blood Leak; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT DURING CANNULATION OF THE ASCENDING AORTA FOR A CARDIOPULMONARY BYPASS CASE, THE CUSTOMER DESCRIBED THAT THE WHITE INTERNAL OBTURATOR DID NOT FIT THE DEVICE AS USUAL. THE CUSTOMER DESCRIBED THAT THE BLOOD PRESSURE IN THE AORTA WAS PUSHING OUT THE OBTURATOR AND THE DEVICE BODY FILLED WITH BLOOD MORE RAPIDLY THAN USUAL. THERE WAS NO RESISTANCE IN WITHDRAWING THE OBTURATOR COMPARED TO THE CUSTOMER'S USUAL EXPERIENCE AND THERE WAS SOME LEAKAGE OF BLOOD FROM THE RED CAP/ WHITE OBTURATOR JUNCTION. THERE WAS NO DAMAGE TO ANY PACKAGING AND THE DEVICE DID NOT LOOK ABNORMAL. THE CUSTOMER WAS A LONG-TERM USER OF THE DEVICE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE, AS IT WAS ALREADY IN THE AORTA AND THERE WERE NO PATIENT ISSUES AND REMAINDER OF THE OPERATION CONTINUED WITHOUT AN EVENT. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE PATIENT BLOOD LOSS WAS MINIMAL (10 ML) BUT WAS SCAVENGED BY THE HEART LUNG MACHINE AND RETURNED TO THE PATIENT. A TRANSFUSION WAS NOT REQUIRED AS

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18516152 ↗
• MalfunctionNov 27, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA CANNULA, IT WAS REPORTED THAT THE SHEATH WAS SHORT. THE CUSTOMER DID NOT USE THE PRODUCT ON THE PATIENT AS THEY OBSERVED THE ISSUE JUST BEFORE CANNULATION. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211928 ↗
• MalfunctionNov 21, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE DEVICE WAS LEAKING WITH NO EXPLANATION AS TO WHAT CAUSED THE LEAK. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO PATIENT BLOOD LOSS AS A RESULT OF THE LEAK. THERE WAS NO UNPLANNED BLOOD TRANSFUSION REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER BELIEVES THE CANNULA LOOKED LIKE IT WAS CRACKED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THE DAMAGE WAS ON THE DISTAL END OF THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18180543 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THIS EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A LEAKAGE AT THE CANNULA MANDREL WHEN REMOVING THE CANNULA GUIDE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE. ADDITIONAL INFORMATION: THE CANNULA WAS NOT HEATED PRIOR TO USE. THE CUSTOMER STATED THAT A BLOOD TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK. THE EXACT AMOUNT OF BLOOD LOST AS A RESULT OF THE LEAK COULD NOT BE PROVIDED BUT THE CUSTOMER STATED THAT IT WAS "A LITTLE BIT". IT WAS NOTED THAT THIS IS NEVER THE CASE WITH 22FR CANNULAS, BUT SOMETIMES WITH 24FR. THE WHITE GUIDE DOES NOT FIT INTO THE RED CAP ON THE 22FR BUT THE GUIDE FITS INTO THE 24FR. IT WAS REPORTED THAT THE CANNULA WAS INTACT BUT THE RED CAP WAS NOT TIGHT AROUND WHITE MANDREL. BLOOD LEAKAGE AT THE TIME OF CANNULATION. CANNULA MUST BE CLAMPED TO REMOVE THE MANDREL AND AVOID BLOOD SPILLAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245622 ↗
• MalfunctionJul 3, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED LEAKAGE AROUND THE GUIDE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.   ADDITIONAL INFORMATION: IT WAS NOTED THAT THIS IS NOT THE FIRST PROBLEM FOR THIS CFN IN THIS CENTER. THE PROBLEM IS NOT NEW AND ALWAYS THE SAME: THE MANDREL SEEMS TOO SMALL FOR THE CANNULA. IT WAS CONFIRMED THAT ALL OF THE PREVIOUS EVENTS HAVE BEEN REPORTED AS COMPLAINTS. THE LEAKAGE WAS FROM AROUND THE MANDREL. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. SUTURES DO NOT SEEM TO BE INVOLVED. THERE WAS LITTLE BLOOD LOST, ESPECIALLY AS THE SURGICAL TEAM IS AWARE OF THIS PROBLEM AND IS EVEN MORE CAUTIOUS WITH THE 24 CANNULA (OFTEN AN OPERATING ASSISTANT KEEPS A FINGER ON THE GUIDE WIRE WHEN INSERTING INTO THE AORTA). THESE CANNULAS ARE USED IN SPITE OF EVERYTHING, BUT THE INSTALLATION IS MORE DELICATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245566 ↗
• MalfunctionJul 3, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA CANNULA THE CUSTOMER OBSERVED A KINK ON THE CANNULA. THE CANNULA WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245059 ↗
• MalfunctionMay 31, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77424 EOPA ARTERIAL CANNULA, THE CUSTOMER OBSERVED BLOOD WAS LEAKING FROM THE CANNULA BETWEEN THE RED CAP AND THE DILATOR. IT WAS ASKED BUT UNKNOWN WHETHER THE DEVICE WAS USED OR REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION: A BLOOD TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THE LEAK. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. THERE WAS NO DAMAGE IN THE LOCATION OF THE SUTURES. THE CUSTOMER COULD NOT PROVIDE THE EXACT QUANTITY OF BLOOD LOST BUT THEY STATED THAT DROPS WERE COMING OUT CONTINUOUSLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17029169 ↗
• MalfunctionMay 25, 2023Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT DURING INSERTION OF THE EOPA ARTERIAL CANNULA INTO THE AORTA THE CUSTOMER REPORTED THE MANDREL DID NOT SEEM STABLE IN THE CANNULA AND LEAKED SLIGHTLY NEAR THE MANDREL INTO THE OPERATING FIELD. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE VOLUME OF BLOOD LOST WAS SMALL. A BLOOD TRANSFUSION WAS NOT REQUIRED AND THERE WAS NO PATIENT IMPACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002357 ↗
• MalfunctionMay 25, 2023Leak/Splash; Leak/Splash

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A 77424 EOPA CANNULA, THE CUSTOMER NOTICED LEAKAGE AROUND THE MANDREL WHEN REMOVING THE GUIDE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS A SMALL AMOUNT OF BLOOD LOST, NOT MEASURABLE. THERE WAS NO PATIENT IMPACT REPORTED. ADDITIONAL INFORMATION: THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002070 ↗

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-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-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-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