EOPA™ 77618Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 20763000135656), received between Jul 6, 2021 and Sep 14, 2026 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Deformation

  Medtronic received information that prior to use of a 18FR EOPA Arterial Cannula, it was reported that the device was damaged and kinked. The device was replaced. There was no patient involvement, so no adverse effect occurred.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50757015 ↗
• DeathJul 6, 2021Material Puncture/Hole; Material Puncture/Hole

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77618 EOPA ARTERIAL CANNULA, A FRACTURE OF THE CANNULA WAS REPORTED. THE PATIENT HAD BEEN ON EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY FOR 12 DAYS, BEFORE A BLOOD PRESSURE ALARM DISPLAYED ON THE VITAL SIGNS MONITOR. WHEN THE NURSE ENTERED THE ROOM, THEY FOUND THE PATIENT IN PSYCHOMOTOR AGITATION, PROFUSE BLEEDING FROM THE RIGHT JUGULAR CANNULATION SITE, AND IMMEDIATE DYSFUNCTION OF ECMO THERAPY. IN THE JUGULAR AREA OF THE NECK, IT WAS FOUND THAT THE PATIENT WAS STILL CANNULATED BY THE DISTAL END OF THE ARTERIAL CANNULA. HOWEVER THE CANNULA WAS FRACTURED AND THE FIXATION SITES WERE INTEGRAL (IN THE NECK, SCALP AND SHOULDER). WHEN CHECKING THE CANNULA, A FRACTURE WAS OBSERVED IN A PORTION ANTERIOR TO THE CLAMPING AREA. ADVANCED RCCP WAS STARTED, 5 EPINEPHRINE AMPOULES, JET NOREPINEPHRINE, CRYSTALLOID RESUSCITATION AND 3 UNCROSSED BLOOD PACKETS WERE ADMINISTERED AS TREATMENT. THE PATIENT WAS WITHOUT VITAL SIGNS DESPITE RESUSCITATION MANEUVERS. THE ECMO DOCTOR ELECTED TO SUSPEND RE SUSCITATION MANEUVERS AND THE PATIENT DIED ON THE SAME DAY. THE PATIENT WAS AN ADULT PATIENT WITH A SARS-COV2 INFECTION, DUE TO ITS CLINICAL COMP

  Patient problems: Exsanguination; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 12120036 ↗

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-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