EOPA™ 77624Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 20763000135687), received between May 25, 2023 and Feb 21, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 21, 2025Fluid/Blood Leak; Mechanical Problem; Fluid/Blood Leak; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT DURING CANNULATION OF THE AORTA (UNDER NORMAL BLOOD PRESSURE CONDITIONS) THE SURGEON EXPERIENCED A NUMBER OF INSTANCES (APPROXIMATELY X4) WHERE THE WHITE OBTURATOR SLIPPED OUT OF THE CANNULA PREMATURELY CAUSING EXCESSIVE BACK BLEEDING. SITUATION WAS DEALT WITH BY REMOVING THE OBTURATOR TO THE POINT AT WHICH A CLAMP COULD BE APPLIED TO ESTABLISH CONTROL. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21432496 ↗
• MalfunctionNov 14, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THEY DISCOVERED THAT THE CANNULA HAS A STRONG KINKING TENDENCY ABOUT 10CM FROM THE DISTAL TIP. THE CUSTOMER REPORTED THAT THIS ISSUE IS NOT ABLE TO BE DETECTED UNTIL THE DEVICE IS IN THE AORTA AND THE INTRODUCER IS REMOVED. THE CUSTOMER STATED THAT THEY WERE SUPER CAREFUL TO SECURE THE DEVICE IN SUCH A WAY THAT IT CANNOT KINK DURING THE PROCEDURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER REPORTING THE EOPA COMPLAINT EXPLAINED THAT THEIR TECHNIQUE IS TO BLAME FOR THE CANNULA KINK. THEY SAID ABOUT TWO MONTHS AGO THEY BEGAN DOING SOMETHING DIFFERENT TO FILL THE CANNULA WITH BLOOD AND DE-AIR IT PRIOR TO CONNECTING IT TO THE PATIENT CIRCUIT. IN THE PAST, THEY ALWAYS JUST ALLOWED THE ARTERIAL BLOOD TO PASSIVELY FILL THE CANNULA AND THE BLOOD WAS DIRECTED INTO A STERILE BOWL ON THE SURGICAL FIELD. TWO MONTHS AGO, THEY BEGAN SKIPPING THE STERILE BOWL STEP AND BENT THE EOPA CANNULA SHARPLY AND ALLOWED THE ARTERIAL BLOOD TO JUST GO BACK INTO THE PATIENT¿S CHEST.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129304 ↗
• MalfunctionNov 10, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A KINK IN THE DEVICE IN THE AREA THAT THE CUSTOMER STATED IS PRONE TO GETTING A KINK IF THE DEVICE IS MOVED IN A CERTAIN WAY. THE CUSTOMER STATED THAT THE AREA IN QUESTION IS APPROXIMATELY 10CM FROM THE DISTAL TIP OF THE DEVICE. THE CUSTOMER STATED THAT THEY ARE VERY AWARE OF THIS ISSUE BECAUSE THEY HAVE REPORTED SEVERAL OF THESE IN THE LAST COUPLE OF MONTHS. THE CUSTOMER IS VERY CAREFUL TO SECURE THE CANNULA IN SUCH A WAY THAT IT CANNOT KINK AND CAUSE ANY PATIENT IMPACT AT ALL. THE DEVICE WAS USED 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 PRIOR TO USE. THE KINK WAS NOT IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18109466 ↗
• MalfunctionNov 8, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A KINK IN THE DEVICE IN THE AREA THAT THE CUSTOMER STATED IS PRONE TO GETTING A KINK. THE CUSTOMER STATED THAT THIS ISSUE WAS NOT DETECTABLE UNTIL THE CANNULA WAS INSERTED INTO THE PATIENT'S AORTA. THE CUSTOMER IS AWARE OF THE POSSIBILITY OF KINKING DUE TO THE CUSTOMER'S EXPERIENCES WITH THE ISSUE. THE CUSTOMER STATED THAT THEY SECURED AND POSITIONED THE CANNULA IN A MANNER THAT PREVENTS IT FROM KINKING AND AFFECTING THE PATIENT BLOOD FLOW. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 KINK WAS NOT IN THE LOCATION OF THE SUTURES. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER EXPLAINED THAT THEIR TECHNIQUE IS TO BLAME FOR THE CANNULA KINK. THE CUSTOMER STATED THAT ABOUT TWO MONTHS AGO THEY BEGAN DOING SOMETHING DIFFERENT TO FILL THE CANNULA WITH BLOOD AND DE-AIR IT PRIOR TO CONNECTING IT TO THE PATIENT CIRCUIT. IN THE PAST, THEY ALWAYS JUST ALLOWED THE ARTERIAL BLOOD TO PASSIVELY FILL THE CANNU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18091899 ↗
• MalfunctionNov 7, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THERE WAS KINKING ABOUT 10CM FROM THE TIP OF THE DEVICE. THE CUSTOMER STATED THAT THE KINKING IS NOT NOTICEABLE UNTIL THE DEVICE IS INSERTED INTO THE AORTA. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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 KINK WAS NOT IN THE LOCATION OF THE SUTURES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18083023 ↗
• MalfunctionSep 7, 2023Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THE DEVICE ¿FELT FLIMSY AND THE WIRE REIN FORCEMENT DOES NOT SEEM TO SUPPORT THE CANNULA LUMEN AS INTENDED¿. THE CANNULA WAS LEFT IN PLACE IN THE AORTA FOR THE DURATION OF THE CARDIOPULMONARY BYPASS PART OF THE PROCEDURE AND THE ISSUE DID NOT REQUIRE IT TO BE REPLACED. THERE WAS NO FUNCTIONAL DIFFERENCE NOTED BUT IT FEELS DIFFERENT ACCORDING TO THE SURGEON. THE DEVICE WAS USED 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 ISSUE. A BLOOD TRANSFUSION WAS NOT REQUIRED. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17697158 ↗
• MalfunctionMay 25, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77624 EOPA ARTERIAL CANNULA, THE PLUG THAT CLOSES THE LIGHT OF THE GUIDE AT THE END OF THE INTRODUCER WAS STUCK. IT WAS IMPOSSIBLE TO REMOVE THE PLUG, AND IT BROKE WHEN FORCED. THE CANNULA WAS CHANGED OUT WITH ABACKUP AND THERE WAS NO RESULTING ADVERSE PATIENT EFFECT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002212 ↗

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-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-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