EOPA 3D® 78222 (UDI 20763000135700)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 20763000135700), received between May 26, 2023 and Apr 30, 2026 — classified as 1 injury, 5 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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

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-2810-2026 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 30, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED THAT DURING THE PLACEMENT OF THE EXTRACORPOREAL CIRCULATION, THE AORTIC CANNULA WAS PIERCED AT THE LEVEL OF ITS REINFORCED PART. 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 25039578 ↗
• InjuryApr 29, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE EOPA 3D ARTERIAL CANNULA WAS USED TO CANNULATE THE PATIENT¿S AORTA AND WAS CONNECTED TO THE ARTERIAL LINE OF THE CARDIOPULMONARY BYPASS CIRCUIT. AFTER CANNULATION, A SMALL JET OF BLOOD WAS OBSERVED COMING FROM THE WIRE-WOUND SECTION OF THE CANNULA, INDICATING A BLOOD LEAK. MINIMAL BLOOD LOSS OF LESS THAN 50 ML WAS REPORTED, WITH NO TRANSFUSION REQUIRED. THERE WAS NO DAMAGE OBSERVED TO THE PACKAGING AND NO OBVIOUS DAMAGE TO THE CANNULA. BONE WAX WAS APPLIED TO STOP THE BLOOD JET, AND THE PROCEDURE WAS COMPLETED USING THE SAME CANNULA.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25030982 ↗
• MalfunctionApr 27, 2026Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED THAT DURING THE PLACEMENT OF THE EXTRACORPOREAL CIRCULATION, THE CUSTOMER DISCOVERED THAT THE AORTIC CANNULA WAS PIERCED AT THE LEVEL OF ITS REINFORCED PART. 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 25007991 ↗
• MalfunctionApr 10, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT, DURING CANNULATION USING THE EOPA 3D VENTED ARTERIAL CANNULA, A LEAK FROM THE CANNULA WAS IDENTIFIED WHEN A PINHOLE WAS DETECTED IN THE WIRE-WOUND PORTION OF THE ARTERIAL CANNULA. NO PATIENT BLOOD LOSS WAS REPORTED, AND NO UNPLANNED BLOOD TRANSFUSION WAS REQUIRED. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24842816 ↗
• MalfunctionAug 25, 2025Air/Gas in Device; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED THAT 3CC BOLUS OF AIR WAS OBSERVED AT THE END OF THE CANNULA AT THE END OF THE PROCEDURE. AIR WAS NOT OBSERVED WITHIN THE CANNULA WALL. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. IT WAS UNKNOWN IF THERE WAS ANY COMPLICATIONS AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22882298 ↗
• MalfunctionMay 26, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 78222 EOPA 3D CANNULA, WHEN THE SURGEON WAS INSERTING THE CANNULA THE RED CAP POPPED OFF DURING INSERTION. THERE WAS GREATER THAN NORMAL BLOOD LOSS AND IT WAS DIFFICULT TO CLAMP THE CANNULA DUE TO THE WHITE STYLET NOT BEING VISUALIZED. THE CASE PROCEEDED WITH THE SAME CANNULA. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THERE WAS NO PATIENT HARM AND THE CASE PROCEEDED, BUT APPARENTLY THIS HAS HAPPENED MULTIPLE TIMES. THE CUSTOMER DOES NOT HAVE A RECORD OF HOW MANY OCCURRENCES OR DETAILS OF THE OTHER EVENTS. THE CUSTOMER SAID THAT THEY THOUGHT IT WAS A FEW ISOLATED EVENTS, BUT NOW THE SURGEON FEELS IT'S A CANNULA ISSUE. THEY DID ALSO MENTION IT IS LIKE THE OBTURATOR IS NOT SEALING WITH THE RED CAP AND BLOOD IS COMING UP THROUGH IT. THE HCP WAS UNABLE TO PROVIDE THE EXACT BLOOD LOSS IN ML. THERE WAS NO BLOOD TRANSFUSION NEEDED DUE TO THE LEAK. THE CAP WAS NOT DAMAGED IN ANYWAY NOR WAS IT LOOSE PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17010135 ↗