EOPA™ 77620 (UDI 20763000946818)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20763000946818), received between Aug 28, 2025 and Nov 18, 2025 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 reports).

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

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.

• InjuryNov 18, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE INTRODUCER WAS FULLY LOADED INTO THE CANNULA, AND THE TIP OF THE INTRODUCER SNAPPED OFF. THE PIECE WAS ABLE TO BE RETRIEVED. THERE WAS NO VISIBLE SIGN OF DAMAGE TO THE PACKAGING. SEE ATTACHED PHOTO. 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 23585866 ↗
• MalfunctionNov 12, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA FOR EXTRACORPOREAL CIRCULATION HAD A MANUFACTURING DEFECT, PLASTIC WAS MISSING FROM THE DILATOR, MAKING THE SHAPE LESS THAN COMPLETELY CONICAL PRIOR TO USE. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE MISSING PLASTIC PIECE FROM THE DILATOR WAS NOT RECOVERED. THE CANNULA WAS NOT HEATED OR COOLED PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23531375 ↗
• MalfunctionOct 16, 2025Break; Break

  IT WAS REPORTED THAT DURING INSERTION OF THE EOPA ARTERIAL CANNULA, THE END CAP OF THE STYLETTE BROKE OFF CLEANLY, DESCRIBED AS SIMILAR TO SNAPPING OFF A PIECE OF FOAM. THE BROKEN PIECE WAS RETRIEVED. THE USE OF THE DEVICE WAS UNSPECIFIED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23309076 ↗
• MalfunctionAug 28, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE OF AN EOPA ARTERIAL CANNULA UPON OPENING OF THE PACKAGING, IT WAS OBSERVED THAT THE END TIP WAS BROKEN. THE DEVICE WAS REPLACED. THERE WERE NO PATIENT COMPLICATIONS REPORTED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT UPON FURTHER VERIFICATION WITH THE CUSTOMER, WHAT THEY CAN RECALL IS, ONE OF THE END OF THE CANNULA WAS BROKEN ON THE POROUS PLUG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22911328 ↗

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-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-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-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-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