EOPA™ 77420 (UDI 20763000135625)Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 20763000135625), received between Aug 2, 2022 and Sep 24, 2026 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · FDA record ↗

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 24, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50885622 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691920 ↗
• MalfunctionSep 9, 2026Fluid/Blood Leak; Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50691615 ↗
• MalfunctionDec 18, 2025Delivered as Unsterile Product; Material Deformation; Delivered as Unsterile Product; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE TIP WAS DAMAGED AND DEFORMED. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE TIP WAS DEFORMED AND NOT DETACHED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23840602 ↗
• MalfunctionMay 15, 2025Contamination; Contamination

  IT WAS REPORTED THAT A HAIR WAS FOUND IN THE PACKAGE OF THE EOPA ARTERIAL CANNULA BEFORE USE. THE HAIR WAS OBSERVED BEFORE OPENING THE PACKAGE AND GIVING THE CANNULA TO THE SCRUB NURSE, AND IT WAS NOT USED BY THE SURGEON. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIER WAS STILL SEALED WHEN FM WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22025984 ↗
• MalfunctionDec 3, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE SCRUB NURSE NOTICED THE STYLET WAS LOOSE, AND THE INNER SHEATH AND STYLET DID NOT FEEL LIKE NORMAL. THE SURGEON AGREED THAT THE STYLET WAS NOT SITTING AS IT USUALLY DOES. THEY OPENED ANOTHER CANNULA, AND IT WAS OKAY. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. IT WAS ALSO REPORTED THAT THE CUSTOMER HAD THIS SAME ISSUE AT ANOTHER HOSPITAL WITH THE 20FR EOPA CANNULA, ON MULTIPLE OCCASIONS. THE PREVIOUS OCCURRENCES WERE NOT REPORTED TO MEDTRONIC, SO HAVE BEEN CAPTURED IN THIS PE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ISSUE WITH THE DEVICE WAS NOTED PRIOR TO INSERTION INTO PATIENT. THE CUSTOMER NOTED THAT THE INNER WHITE DILATOR CAME OUT TOO EASILY, UPON MANIPULATION OF THE WHITE INNER DILATOR, IT WAS NOTED THAT IT DOES SEEM TO MOVE IN AND OUT OF THE CANNULA VERY EASILY, WITHOUT AS MUCH FORCE THAN WHAT IS USUALLY REQUIRED. THERE IS USUALLY MORE RESISTANCE UPON PULLING THE INNER DILATOR OUT. THE TOTAL NUMBER OF OCCURRENCES IS UNKNOWN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20831028 ↗
• MalfunctionOct 2, 2024Mechanical Problem; Misassembled During Installation; Mechanical Problem; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE WHITE INTRODUCER STUCK OUT TWICE AS FAR AS BEFORE AT THE TIP. IT WAS HARDER TO REMOVE FROM THE CANNULA. THE USE OF THE DEVICE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20350938 ↗
• MalfunctionAug 6, 2024Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT WHEN INSERTING THE CANNULA INTO THE PATIENT, THE INNER DILATOR FLEW OUT OF THE CANNULA CAUSING BLOOD TO SPRAY OUT OF THE END OF THE CANNULA. THERE WAS NO SIGNIFICANT AMOUNT OF BLOOD LOSS AS IT SPRAYED INTO THE SURGICAL FIELD. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 19916128 ↗
• MalfunctionNov 27, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT IT WAS DAMAGED. THE USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211162 ↗
• MalfunctionNov 22, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A  EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT IT WAS DAMAGED.THE USE OF THE DEVICE WAS NOT SPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18190851 ↗
• MalfunctionNov 6, 2023Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THERE WAS A HOLE IN THE SIDE OF THE CANNULA. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE HOLE WAS APPROXIMATELY 1 INCH FROM THE TIP OF THE CANNULA. THE HOLE WAS VERY SMAL L, SUCH THAT THE CUSTOMER DID NOT SEE IT UNTIL SOME BLOOD BEGAN TO OOZE FROM IT. THERE WAS A SMALL LEAK FROM THE HOLE WHICH WAS ABOUT 1 INCH FROM THE CANNULA TIP IN THE WIRE WOUND SECTION. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE. NO DAMAGE IN THE LOCATION OF THE SUTURES, HOWEVER THE CUSTOMER QUERIED WHETHER THE DAMAGE MAY HAVE BEEN CAUSE BY TRAUMA FROM A NEEDLE BUT THE SCRUB NURSE DENIED THAT THIS COULD HAVE HAPPENED. THERE WAS NO BLOOD LOSS AS THE SURGEON USED BONE WAX TO SEAL THE HOLE AND CONTINUED WITH THE CASE. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18072407 ↗
• MalfunctionJun 6, 2023Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE DEVICE LEAKED. MEASURES SUCH AS PARAFFIN WERE USED TO SEAL IT. THE USE OF THE DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17069577 ↗
• MalfunctionMay 12, 2023Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE DURING INSPECTION, THE CUSTOMER NOTICED A CRACK IN THE 20FR EOPA ARTERIAL CANNULA AT THE 3/3X3/8 LL CONNECTOR. THEY CUT OUT THE LUER LOCK AND THE 3/8X3/8 CONNECTOR OF THE CANNULA AND ADDED A NEW 3/8X3/8 STRAIGHT CONNECTOR. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL INFORMATION FROM THE CUSTOMER: THE CUSTOMER INSPECTED AND OBSERVED THE CRACK IN THE ARTERIAL CANNULAE AS HE WAS ABOUT TO USE IT. THE SIZE OF THE CRACK WAS OBVIOUS ENOUGH FOR THE CUSTOMER TO CHANGE OUT THE CANNULA. THEY DID NOT USE THE CANNULA AFTER THE CRACK WAS NOTED. NO BLOOD TRANSFUSION WAS REQUIRED AS A RESULT OF THE CRACK. NO DAMAGE WAS NOTICED TO THE DEVICE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918907 ↗
• MalfunctionAug 2, 2022Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED A PROBLEM WHILE INSERTING THE CANNULA, THE TROCAR CAME OUT AND SPRAYED PEOPLE AT THE OPERATING TABLE. ADDITIONAL INFORMATION IS REQUESTED TO DETERMINE IF THE CANNULA WAS REPLACED. THERE WAS NO PATIENT IMPACT REPORTED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15144899 ↗

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