EOPA 3DRecalls & reported problems across all models

We found 8 models of EOPA 3D by Medtronic, Inc. in the FDA's device registry (GUDID). Together they are named in 27 adverse event reports in the FDA's MAUDE database, received between Mar 23, 2018 and Sep 22, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (14 reports).

2 FDA recall records name at least one of these models by its device identifier, 2 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

EOPA 3D recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

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-2811-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. 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 · Recall details · FDA record ↗

Most reported EOPA 3D problems

EOPA 3D models

8 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EOPA 3D® 78322

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 recall12 reports
• EOPA 3D® 78222

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 recall6 reports
• EOPA 3D® 78220

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  3 reports
• EOPA 3D® 78220

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  2 reports
• EOPA 3D® 78220

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• EOPA 3D® 78222

  CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
  1 report
• EOPA 3D® 78322

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 report
• EOPA 3D® 78222

  Catheter, cannula and tubing, vascular, cardiopulmonary bypass
  1 report

Recent EOPA 3D adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Nonstandard Device

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50857341 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, IT WAS NOTED THAT TWO EOPA 3D ARTERIAL CANNULAE HAD HOLES IN THE UPPER PART THAT WERE LEAKING. THE USE OF THE CANNULAE WAS UNSPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25275680 ↗
• MalfunctionMay 26, 2026Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT AT AN UNSPECIFIED TIME, IT WAS NOTED THAT TWO EOPA 3D ARTERIAL CANNULAE HAD HOLES IN THE UPPER PART THAT WERE LEAKING. THE USE OF THE CANNULAE WAS UNSPECIFIED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25275668 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  THIS COMPLAINT RECORD HAS BEEN CREATED TO CAPTURE THE SEVEN EOPA 3D ARTERIAL CANNULAE RETURNED ON COMPLAINT EVENT (B)(4). PARENT EVENT HAS BEEN REPORTED BY CUSTOMER FOR CANNULA LEAKED OUT OF THE SIDE WHILE IT WAS INSERTED INTO THE AORTA. THE PRODUCTS INVOLVED WITH THIS COMPLAINT HAVE NOT BEEN USED AND RETURNED FOR ANALYSIS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227594 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  THIS COMPLAINT RECORD HAS BEEN CREATED TO CAPTURE THE SEVEN EOPA 3D ARTERIAL CANNULAE RETURNED ON COMPLAINT EVENT (B)(4). PARENT EVENT HAS BEEN REPORTED BY CUSTOMER FOR CANNULA LEAKED OUT OF THE SIDE WHILE IT WAS INSERTED INTO THE AORTA. THE PRODUCTS INVOLVEDWITH THIS COMPLAINT HAVE NOT BEEN USED AND RETURNED FOR ANALYSIS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227563 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  THIS COMPLAINT RECORD HAS BEEN CREATED TO CAPTURE THE SEVEN EOPA 3D ARTERIAL CANNULAE RETURNED ON COMPLAINT EVENT (B)(4). PARENT EVENT HAS BEEN REPORTED BY CUSTOMER FOR CANNULA LEAKED OUT OF THE SIDE WHILE IT WAS INSERTED INTO THE AORTA. THE PRODUCTS INVOLVEDWITH THIS COMPLAINT HAVE NOT BEEN USED AND RETURNED FOR ANALYSIS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227558 ↗
• MalfunctionMay 20, 2026Fluid/Blood Leak; Material Puncture/Hole

  THIS COMPLAINT RECORD HAS BEEN CREATED TO CAPTURE THE SEVEN EOPA 3D ARTERIAL CANNULAE RETURNED ON COMPLAINT EVENT (B)(4). PARENT EVENT HAS BEEN REPORTED BY CUSTOMER FOR CANNULA LEAKED OUT OF THE SIDE WHILE IT WAS INSERTED INTO THE AORTA. THE PRODUCTS INVOLVEDWITH THIS COMPLAINT HAVE NOT BEEN USED AND RETURNED FOR ANALYSIS ONLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25227496 ↗
• MalfunctionMay 6, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING AN AORTIC CANNULATION PROCEDURE, AN EOPA 3D ARTERIAL CANNULA  LEAKED OUT OF THE SIDE WHILE IT WAS INSERTED INTO THE AORTA. IT WAS REPORTED THAT NO BLOOD LOSS OCCURRED DUE TO THE LEAK AND NO UNPLANNED BLOOD TRANSFUSION WAS REQUIRED. USE OF THE CANNULA WAS CONTINUED TO COMPLETE THE CASE AND THE DEVICE WAS NOT REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25092201 ↗
• 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 28, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED A LEAK FROM THE CANNULA. PATIENT BLOOD LOSS WAS REPORTED DUE TO THE LEAK, ALTHOUGH THE AMOUNT WAS NOT AVAILABLE, AND AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25018482 ↗
• MalfunctionApr 28, 2026Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED A LEAK FROM THE CANNULA. PATIENT BLOOD LOSS WAS REPORTED DUE TO THE LEAK, ALTHOUGH THE AMOUNT WAS NOT AVAILABLE, AND AN UNPLANNED BLOOD TRANSFUSION WAS NOT REQUIRED. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25018398 ↗
• 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 21, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PROCEDURE REQUIRING AORTIC CANNULATION FOR CARDIOPULMONARY BYPASS USING AN EOPA 3D ARTERIAL CANNULA FOR MITRAL VALVE SURGERY, A HOLE WAS OBSERVED IN THE WIRE-WOUND PORTION OF THE FIRST CANNULA AND A SMALL BLOOD JET WAS SEEN FROM THAT AREA. THE ESTIMATED PATIENT BLOOD LOSS WAS APPROXIMATELY 20 ML. THE LEAK OCCURRED AFTER CONNECTION TO THE PERFUSION CIRCUIT, FLOW WAS INITIATED BUT THE PATIENT WAS NOT CROSS CLAMPED YET. THE FIRST CANNULA WAS REMOVED AND REPLACED WITH AN IDENTICAL EOPA 3D ARTERIAL CANNULA, AND THE SAME ISSUE OCCURRED. A HOLE AND LEAK IN THE SAME REGION OF THE WIRE-WOUND PORTION, WAS OBSERVED WITH THE SECOND CANNULA. THE ESTIMATED PATIENT BLOOD LOSS FOR THE SECOND CANNULA WAS LESS THAN 20 ML. THE SECOND CANNULA WAS ALSO REMOVED AND REPLACED. A THIRD CANNULA OF A DIFFERENT SIZE WAS THEN USED TO COMPLETE THE PROCEDURE. THE PATIENT REQUIRED THREE CANNULATION ATTEMPTS, WHICH DELAYED GOING ONTO CARDIOPULMONARY BYPASS BY APPROXIMATELY 10 MINUTES AND INCREASED PROCEDURE TIME. THERE WAS ALSO AN INCREASED RISK OF COMPLICATIONS ASSOCIATED WITH REPEATED CANNULATION. NO ADDITIONAL FLUID OR BLOOD TRANSFUSION WAS REQUIRED. NO CLAMPS WERE P LACED ON THE W

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24938197 ↗
• MalfunctionApr 21, 2026Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED THAT DURING A PROCEDURE REQUIRING AORTIC CANNULATION FOR CARDIOPULMONARY BYPASS USING AN EOPA 3D ARTERIAL CANNULA FOR MITRAL VALVE SURGERY, A HOLE WAS OBSERVED IN THE WIRE-WOUND PORTION OF THE FIRST CANNULA AND A SMALL BLOOD JET WAS SEEN FROM THAT AREA. THE ESTIMATED PATIENT BLOOD LOSS WAS APPROXIMATELY 20 ML. THE LEAK OCCURRED AFTER CONNECTION TO THE PERFUSION CIRCUIT, FLOW WAS INITIATED BUT THE PATIENT WAS NOT CROSS CLAMPED YET. THE FIRST CANNULA WAS REMOVED AND REPLACED WITH AN IDENTICAL EOPA 3D ARTERIAL CANNULA, AND THE SAME ISSUE OCCURRED. A HOLE AND LEAK IN THE SAME REGION OF THE WIRE-WOUND PORTION, WAS OBSERVED WITH THE SECOND CANNULA. THE ESTIMATED PATIENT BLOOD LOSS FOR THE SECOND CANNULA WAS LESS THAN 20 ML. THE SECOND CANNULA WAS ALSO REMOVED AND REPLACED. A THIRD CANNULA OF A DIFFERENT SIZE WAS THEN USED TO COMPLETE THE PROCEDURE. THE PATIENT REQUIRED THREE CANNULATION ATTEMPTS, WHICH DELAYED GOING ONTO CARDIOPULMONARY BYPASS BY APPROXIMATELY 10 MINUTES AND INCREASED PROCEDURE TIME. THERE WAS ALSO AN INCREASED RISK OF COMPLICATIONS ASSOCIATED WITH REPEATED CANNULATION. NO ADDITIONAL FLUID OR BLOOD TRANSFUSION WAS REQUIRED. NO CLAMPS WERE PLACED ON THE WI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24938178 ↗

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