EOPA™ 77422 (UDI 20763000946788)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 20763000946788), received between Jun 26, 2025 and Apr 23, 2026 — classified as 1 injury, 7 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Break

  IT WAS REPORTED THAT, PRIOR TO USE, AN EOPA ARTERIAL CANNULA HAD A BROKEN PLUG AND THE PLUG COULD NOT BE PULLED OUT AS INTENDED TO INSERT THE GUIDEWIRE, PREVENTING GUIDEWIRE INSERTION. 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 24964251 ↗
• MalfunctionJan 27, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CANNULA BENT, BUT IT WAS STILL ABLE TO GET FLOW THROUGH THE DEVICE. SEE ATTACHED PHOTO. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24189421 ↗
• MalfunctionJan 6, 2026Component Missing; Misassembled During Installation

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS NO WHITE COLLAR IN PACK THEREFORE PRODUCT COULD NOT BE USED. 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 23971790 ↗
• InjuryNov 26, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT DURING CARDIAC SURGERY, THE WHITE "DEAD-ENDER" CAP ON THE EOPA ARTERIAL CANNULA CAME OFF TWICE. PRIOR TO THE PROCEDURE, BOTH THE REGISTERED NURSE AND THE SURGEON HAD TIGHTENED THE CAP. SHORTLY AFTER INITIATION OF CARDIOPULMONARY BYPASS, THE CAP DETACHED FROM THE CANNULA. THE SURGEON RE-SECURED AND TIGHTENED THE CAP, BUT IT DETACHED AGAIN SOON AFTER. THE SURGICAL TEAM THEN REPLACED THE CAP WITH A ONE-WAY STOPCOCK ON THE CANNULA, AFTER WHICH NO FURTHER ISSUES OCCURRED. BOTH INSTANCES RESULTED IN BLOOD LOSS AND DELAYS TO THE SURGICAL PROCEDURE WHILE THE ISSUE WAS RESOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CAP WAS NOT DAMAGED PRIOR TO USE. NO UNPLANNED BLOOD TRANSFUSION WAS REQUIRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE SURGEON AND THE PERFUSIONIST BOTH CONFIRMED THAT THERE WAS LESS THAN 50MLS OF BLOOD LOSS AS THEY WERE ABLE TO CATCH AND RESOLVE IT IMMEDIATELY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23654440 ↗
• MalfunctionNov 19, 2025Break; Mechanical Problem; Break; Mechanical Problem

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA BROKE PRIOR TO AORTIC CANNULATION. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23591976 ↗
• MalfunctionAug 12, 2025Fluid/Blood Leak; Material Deformation; Fluid/Blood Leak; Material Deformation

  IT WAS REPORTED THAT A LEAK WAS DETECTED IN THE EOPA ARTERIAL CANNULA DURING CENTRAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) CANNULATION. THE LEAK WAS NOTICED SOON AFTER INITIATING ECMO AT A FLOW OF APPROXIMATELY 3.5 LITRES AND WAS NOT OBSERVED AT LOWER FLOWS. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 22780693 ↗
• MalfunctionJul 24, 2025Device Markings/Labelling Problem; Material Deformation; Device Markings/Labelling Problem; Material Deformation

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA WAS FOUND TO HAVE FADED MARKINGS NEAR THE RING INSERTION SITE AND CONTAMINATION WAS OBSERVED ON THE WHITE SHEATH PORTION BENEATH THE RED CAP AT THE TOP UPON OPENING THE PRODUCT PACKAGING PRIOR TO USE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER CONFIRMED THAT IT APPEARED THAT NO FOREIGN MATERIAL (FM) WAS OBSERVED IN THE PRODUCT. HOWEVER, THE MARKER OF THE PRODUCT WAS ERASED, AND THERE WAS A DENT ON THE CAP, WHICH LED THE CUSTOMER TO DETERMINE THAT THE PRODUCT WAS DEFECTIVE AND UNSUITABLE FOR USE IN A PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIER WAS STILL SEALED WHEN THE FOREIGN MATERIAL (FM) WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22585449 ↗
• MalfunctionJun 26, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THE EOPA ARTERIAL CANNULA, THE DEVICE WAS KEPT STRAIGHT MANUALLY. UPON AORTIC CANNULATION NO DEFECTS WERE NOTED. THE INTRODUCER DILATOR WAS REMOVED AND IT WAS OBSERVED THAT THE CANNULA WAS BENDING. THE CANNULA HAD BEEN KEPT STRAIGHT UNTIL THIS POINT. CANNULATION PRESSURES REMAINED NORMAL. IT WAS STATED THAT THE CANNULA HAS BEEN DISINFECTED. 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 CANNULA WAS DISINFECTED TO BE ABLE TO SEND THE DEVICE FOR EVALUATION. THE CANNULA WAS NOT RE-STERILIZED, ONLY DISINFECTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22335133 ↗

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-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-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