EOPA™ 77422 (UDI 20763000135632)Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 20763000135632), received between Jan 27, 2020 and Sep 21, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (6 reports).

2 FDA recall records name this device's identifier, 2 still open.

5 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. Jun 24, 2026Open, Classified

   Medtronic received reports of pinhole leaks in the wire-wound body of 22 Fr EOPA 3D Arterial Cannulae and EOPA Elongated One-Piece Arterial Cannulae used during cardiopulmonary bypass procedures.

   Z-2806-2026 · Root cause: Under Investigation by firm · FDA record ↗

2. 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50848653 ↗
• MalfunctionSep 16, 2026Delivered as Unsterile Product

  Medtronic received information that prior to use of a EOPA Arterial Cannula, it was reported that the packaging seal was noted to be crimped on the dilator tubing and the peel pouch was not sealed. The customer mentioned that the package looks like when it was sealed, it may have stamped on the hard plastic straw, imprinting the seal pattern. See attached photos. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50790550 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Medtronic received information that during use of a EOPA Arterial Cannula, a pinhole leak was observed in the cannula body. No patient blood loss occurred, and no unplanned blood transfusion was required. The cannula was replaced to complete the case. There was no adverse patient effect associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50769157 ↗
• MalfunctionSep 15, 2026Fluid/Blood Leak

  Medtronic received information that during use of a EOPA Arterial Cannula, a pinhole leak was observed in the cannula body. No patient blood loss occurred, and no unplanned blood transfusion was required. The cannula was replaced to complete the case. There was no adverse patient effect associated with this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50768521 ↗
• MalfunctionMay 18, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED A HOLE WAS OBSERVED NEAR THE WIREWOUND PORTION. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR.  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 25200064 ↗
• MalfunctionMay 8, 2025Crack; Crack

  IT WAS REPORTED THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE DEVICE HAD A HOLE IN IT. THE DOCTOR ATTEMPTED TO FIX THE CANNULA BUT IT WAS NOT POSSIBLE. THE CANNULA WAS USED TO COMPLETE THE PROCEDURE; IT WAS NOT MOVED DUE TO THE VERY THIN AORTA. SEE ATTACHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO BLOOD LOSS DUE TO THE PRODUCT PROBLEM. NO BLOOD TRANSFUSION WAS REQUIRED. THE PATIENT IS CURRENTLY STABLE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE, IT WAS ONLY INSERTED. THE DAMAGE WAS NOT IN THE LOCATION OF THE SUTURES. PATIENT BLOOD LOSS AS A RESULT OF THIS LEAK WAS APPROXIMATELY 2-5ML. A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS LEAK. THE DOCTOR ATTEMPTED TO FIX THE CANNULA WITH WATERPROOF ADHESIVES.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21984684 ↗
• MalfunctionOct 4, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A SIGNIFICANT KINK IN THE CANNULA. 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 20366947 ↗
• MalfunctionAug 8, 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 THE WHITE INNER DILATOR WAS FOUND TO BE SO LOOSE THAT WHEN INSERTED, THAT THE PRESSURE OF THE BLOOD PUSHED IT OUT OF THE CANNULA LEADING TO BLOOD SQUIRTING OUT THE CANNULA TIP. THE BLOOD FELL MAINLY INTO SURGICAL FIELD, NO SIGNIFICANT BLOOD LOSS AS THE CELL SALVAGE SUCKER WAS USED TO CLEAN UP. 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 19936775 ↗
• MalfunctionApr 23, 2024Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER OBSERVED TWO SECTIONS ON THE DEVICE THAT APPEARED TO BE DAMAGED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE AS REPLACEMENT OF THE DEVICE WAS CONSIDERED TO BE THE GREATER RISK. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19162710 ↗
• MalfunctionOct 10, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THIS DEVICE KINKED DURING CANNULATION, AND THIS IS THE SECOND OCCURRENCE OF THIS ISSUE. 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 17906489 ↗
• MalfunctionOct 10, 2023Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT UPON REMOVING THE CANNULA FROM THE PACKAGING THE VENTED PLUG SNAPPED VERY EASILY WHERE THE VENTED PLUG EXITS THE INTRODUCER HUB. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. THE CUSTOMER STATED THAT THE EXPERIENCED USER OF CANNULA WHO HANDLED THIS DEVICE SUGGESTED THAT THIS WAS VERY UNUSUAL AS VERY LITTLE PRESSURE WAS APPLIED, THEY HANDLED THE CANNULA AS NORMAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17903770 ↗
• MalfunctionSep 12, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA WAS KINKED ON THE NECK OF THE BODY WHERE IT TAPERS OFF. THE CUSTOMER MANAGED TO FIXATE AND CONTINUED TO WORK WITH THE SAME CANNULA. 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 17727865 ↗
• MalfunctionJul 10, 2023Contamination; Contamination

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, THIS EOPA ARTERIAL CANNULA HAD RED PLASTIC NOTED WITHIN THE INTERNAL LUMEN OF THE DEVICE. THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT REPORTED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17286034 ↗
• MalfunctionJul 3, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THIS CANNULA THE CUSTOMER OBSERVED A SMALL CRACK AT THE TIP OF THE CANNULA BODY. THE CANNULA WAS REPLACED FOR THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT SO NO ADVERSE EFFECTS OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245601 ↗
• MalfunctionJun 29, 2023Mechanical Problem; Material Separation; Mechanical Problem; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77422 EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE TIP OF THE CANNULA WAS LOOSE AND THE STYLET WENT THROUGH LONGER THAN NORMAL. DEVICE WAS REPLACED WITH A BACKUP AND THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17224383 ↗
• MalfunctionMay 12, 2023Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77422 EOPA ARTERIAL CANNULA DURING INSERTION, THE SURGEON REPORTED THAT THERE WAS A PIN SIZE HOLE IN THE CANNULA. THE PRODUCT WAS REPLACED. THE CUSTOMER STATED THAT THERE WAS NO BLOOD LOSS AND A TRANSFUSION WAS NOT REQUIRED AS A RESULT OF THIS ISSUE. THERE WERE NO ADVERSE PATIENT EFFECTS AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16918925 ↗
• MalfunctionMay 18, 2022Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT THE OBTURATOR BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428646 ↗
• MalfunctionApr 21, 2022Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT DURING THE AORTIC CANNULATION OF A PATIENT A BEND AT THE BASE OF THE CANNULA REINFORCED STRUCTURE WAS OBSERVED. IT WAS REPORTED THAT THERE WAS LOSS OF TIME FOR THE PLACEMENT OF A SOLUTION AND THE CUSTOMER INSTALLED A GUIDE TO STIFFEN THE CANNULA.. ADDITION INFORMATION RECEIVED CONFIRMS THE ISSUE OCCURRED AFTER INSERTION INTO THE PATIENT, ON REMOVING THE CHUCK.. THERE WAS NO IMPACT ON THE PATIENT AS THE SURGEON WAS ABLE TO STIFFEN THE CANNULA AND IT WAS THEN USED TO COMPLETE THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14165551 ↗
• MalfunctionJan 27, 2020Collapse; Device Handling Problem; Collapse; Device Handling Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN 22FR EOPA ARTERIAL CANNULA, IT WAS NOTED THAT WHEN THE DEVICE WAS BEING PLACED IN THE AORTA THE SURGEON NOTED A KINK IN THE CANNULA. THE SURGEON DECIDED TO CONTINUE WITH THE CANNULA BY STAKING IT WITH PLIERS AND GUIDES. THE CANNULA WAS USED TO COMPLETE THE CASE. THERE WAS NO REPORTED PATIENT ADVERSE EFFECT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9632840 ↗

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-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