EOPA™ 77522 (UDI 20763000135557)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20763000135557), received between May 6, 2021 and Jan 5, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (3 reports).

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THESE EOPA ARTERIAL CANNULAE, THE CUSTOMER ATTEMPTED TO USE THE FIRST CANNULA, HOWEVER, THERE WAS AN ALLEGED PRODUCT ISSUE WHERE THE WHITE INTRODUCER KEPT PUSHING BACK DURING CANNULATION. AS A RESULT, THE FIRST CANNULA WAS REPLACED. THE SECOND CANNULA, ALLOWED CANNULATION, HOWEVER AS THE INTRODUCER WAS WITHDRAWN, BLOOD STARTED TO LEAK OUT AS IF THE INTRODUCER HAD NOT FORMED A SEAL. THE CANNULAE WERE NOT COOLED OR HEATED AND THERE WAS NO VISIBLE DAMAGE TO THE CANNULAE OR PACKAGING. THERE WAS MINIMAL BLOOD LOSS OF APPROXIMATELY 20MLS AND NO FLUID OR BLOOD TRANSFUSION WAS REQUIRED. THE SECOND CANNULA WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23955359 ↗
• MalfunctionJan 5, 2026Mechanical Problem

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING THESE EOPA ARTERIAL CANNULAE, THE CUSTOMER ATTEMPTED TO USE THE FIRST CANNULA, HOWEVER, THERE WAS AN ALLEGED PRODUCT ISSUE WHERE THE WHITE INTRODUCER KEPT PUSHING BACK DURING CANNULATION. AS A RESULT, THE FIRST CANNULA WAS REPLACED. THE SECOND CANNULA, ALLOWED CANNULATION, HOWEVER AS THE INTRODUCER WAS WITHDRAWN, BLOOD STARTED TO LEAK OUT AS IF THE INTRODUCER HAD NOT FORMED A SEAL. THE CANNULAE WERE NOT COOLED OR HEATED AND THERE WAS NO VISIBLE DAMAGE TO THE CANNULAE OR PACKAGING. THERE WAS MINIMAL BLOOD LOSS OF APPROXIMATELY 20MLS AND NO FLUID OR BLOOD TRANSFUSION WAS REQUIRED. THE SECOND CANNULA WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955339 ↗
• MalfunctionSep 17, 2025Contamination; Material Puncture/Hole; Contamination; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF THESE EOPA ARTERIAL CANNULAE, IT WAS REPORTED THAT THERE WERE FOREIGN MATERIAL (FM) CONTAMINATIONS ON THESE DEVICES. HAIR AND BLACK DOTS WERE OBSERVED. THE DEVICES WERE REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE STERILE BARRIERS WERE STILL SEALED WHEN THE FM WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23071843 ↗
• MalfunctionMar 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT PRIOR TO USE, AT THE START OF A CASE, THE EOPA ARTERIAL CANNULA WAS OPENED AND FOUND TO BE UNUSABLE DUE TO A SUSPECTED MANUFACTURING DEFECT. THE CANNULA HAD BEEN STORED IN THE SAME MANNER AS OTHER SIMILAR PRODUCTS. THE PRODUCT WAS REPLACED. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21582920 ↗
• MalfunctionFeb 20, 2025Crack; Crack

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS A BROKEN CANNULA ISSUE. 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 21421904 ↗
• MalfunctionDec 11, 2024Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT BEFORE USING THE PRODUCT THE CUSTOMER NOTICED THAT THE INTRODUCER WAS TOO SMALL FOR THE CANNULA. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20900157 ↗
• MalfunctionMay 25, 2023Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT WHEN THE PLASTIC PROTECTION OF THE CANNULA WAS OPENED, THE CUSTOMER REPORTED THE EOPA ARTERIAL CANNULA HAD A KINK. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO IMPACT TO THE PATIENT ASSOCIATED WITH THE REPORTED EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002433 ↗
• MalfunctionAug 23, 2022Fluid/Blood Leak; Material Separation; Fluid/Blood Leak; Material Separation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN ELONGATED ONE-PIECE ARTERIAL (EOPA) CANNULA, IT WAS REPORTED THAT THERE WAS A HOLE AT THE END OF THE INSERTION STYLETTE. DURING CANNULATION THE CUSTOMER NOTICED THIS BECAUSE BLOOD WAS LEAKING THROUGH IT. AFTER CHECKING A FEW OF THE OTHER CANNULA, THE CUSTOMER REALIZED THAT THERE IS USUALLY A CAP ON THE END OF THE INSERTION STYLETTE WHICH WAS MISSING ON THIS OCCASION. THE CUSTOMER LOCATED THE CAP, WHICH TURNED OUT TO BE IN THE BIN AND HAD COME OFF IN THE PACKET PRIOR TO SURGERY AND WASN'T NOTICED TO BE MISSING UNTIL THAT POINT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15273882 ↗
• MalfunctionDec 10, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA BLUNT TIP ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT AFTER CANNULATION, THE SURGEON WAS APPLYING A SUTURE TO HOLD THE CANNULA IN PLACE WHEN BLOOD WAS SPURTING (LEAKING) FROM THE SIDE OF THE CANNULA FROM THE COIL SECTION ON THE BODY OF THE CANNULA. THE CANNULA WAS REMOVED AND REPLACED WITH A DIFFERENT LOT NUMBER OF 22FR EOPA. THIS CANNULA HAD NO ISSUES AND THE CASE CONTINUED WITHOUT ANY FURTHER INCIDENT. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION RECEIVED: THE SURGEON WAS DOING A BENTALL/ASCENDING AORTIC ARCH PROCEDURE. IT IS UNKNOWN HOW MUCH BLOOD WAS LOST THROUGH WHAT APPEARS TO BE A HOLE IN THE CANNULA. THE PATIENT DID NOT NEED ANY BLOOD PRODUCTS BECAUSE OF THE LEAK IN THE CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12974367 ↗
• MalfunctionMay 6, 2021Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77522 EOPA ARTERIAL CANNULA, THE CANNULA WAS INSERTED INTO THE AORTA. IT WAS CONNECTED TO THE ARTERIAL LINE OF THE CARDIOPULMONARY BYPASS CIRCUIT. AFTER CONNECTION A LEAK WAS OBSERVED AND A SMALL HOLE WAS SEEN IN THE CANNULA. SEE ATTACHED PHOTOS. THE ARTERIAL LINE HAD TO BE DISCONNECTED AND THE CANNULA REMOVED FROM THE PATIENT'S AORTA. A NEW CANNULA WAS INSERTED AND THE OPERATION CONTINUED WITHOUT EVENT. THERE WAS NO FURTHER IMPACT TO THE PATIENT OTHER THAN RE-CANNULATION. ADDITIONAL INFORMATION: NO DAMAGE WAS NOTED TO THE EXTERNAL PACKAGING. BLOOD LOSS WAS MINIMAL. SMALL DRIPS BEING FORCED THROUGH THE HOLE. HOLE WAS SPOTTED VERY QUICKLY SO BLOOD LOSS WAS IMMEASURABLE. NO TRANSFUSION REQUIRED. THERE WAS NO HEATING OR COOLING OF THE CANNULA BEFORE USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11782272 ↗

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-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-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-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-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-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