EOPA 3D® 78322 (UDI 20199150023251)Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 20199150023251), received between Apr 14, 2026 and May 26, 2026 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (11 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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-2811-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• 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 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 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 ↗
• MalfunctionApr 14, 2026Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA 3D ARTERIAL CANNULA, IT WAS REPORTED THAT A BREAK OCCURRED AT THE WIRE WOUND PORTION OF THE DEVICE IT WAS A SMALL BREAK AND IT WAS IN THE LOCATION OF SUTURES. THE HEMOSTATIS CAP WAS NOT USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24875248 ↗