EOPA™ 77622 (UDI 20763000135670)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000135670), received between Oct 15, 2021 and Aug 19, 2026 — classified as 1 injury, 3 malfunctions.

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

2 FDA recall records name this device's identifier, 2 still open.

5 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.

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-2808-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

2. Mar 19, 2024Open, Classified

   Potential for unsealed sterile packing.

   Z-1793-2024 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 19, 2026Material Puncture/Hole

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50321462 ↗
• MalfunctionJul 3, 2023Mechanical Problem; Mechanical Problem

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THERE WAS NO HOLE IN THE CANNULA FOR THE GUIDEWIRE TO GO IN. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT WHEN THE CUSTOMER WAS CANNULATING THE AORTA THEY WENT TO PLACE THE WIRE INTO THE CANNULA AND REALIZED THERE WAS NO WHOLE TO PUT IT THROUGH AND THE CANNULA WAS INADVERTENTLY THROWN OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17245238 ↗
• MalfunctionOct 25, 2022Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, THE CUSTOMER REPORTED THAT DURING A MITRAL REPLACEMENT, THE CANNULA WAS INSERTED IN THE ASCENDING AORTA. WHILE PREPARING FOR VENOUS CANNULATION, THERE WAS A CRACK/FISSURE IN THE CANNULA (ABOUT 7CM FROM THE DISTAL END) WITH EVIDENT BLOOD LEAKAGE. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT.

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

  MAUDE report 15666956 ↗
• InjuryOct 15, 2021Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA CANNULA, THE CUSTOMER REPORTED BLOOD DROPLETS COMING FROM A PUNCTURE. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS PROVIDED THAT CUSTOMER SEALED THE PUNCTURE WITH BONE WAX TEMPORARILY TO COMPLETE THE PROCEDURE. ADDITIONAL INFORMATION RECEIVED INDICATES IT IS UNKNOWN HOW MUCH BLOOD WAS LOST, ONLY BLOOD DROPLETS WERE SEEN BUT THE SMALL HOLE WAS IMMEDIATELY SEALED BY BONE WAX. A BLOOD TRANSFUSION WAS NOT REQUIRED. THE HOLE IS NOT VISIBLE BUT THE LEAK APPEARS TO BE FROM THE CANNULA. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12639221 ↗

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-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-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-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