EOPA™ 77418 (UDI 20763000135618)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20763000135618), received between Jun 18, 2025 and Feb 19, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling Problem” (3 reports).

1 FDA recall record name this device's identifier, 1 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Dec 12, 2024Open, Classified

   Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.

   Z-0985-2025 · Root cause: Packaging · FDA record ↗

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 19, 2026Contamination; Material Deformation

  IT WAS REPORTED THAT THE EOPA ARTERIAL CANNULA PRODUCT EXHIBITED AN APPEARANCE OF THREE WHITE DOTS AND TIP DAMAGE. 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 24386320 ↗
• MalfunctionJun 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULAE, IT WAS REPORTED THAT THE CUSTOMER OPENED A NEW BOX OF 77422 CANNULA (LOT NUMBER: 2023020934) AND IT CONTAINED 17 PACKETS LABELLED 77422 CANNULA AND 3 PACKETS LABELLED 77418 CANNULA. HOWEVER, THE 3 PACKETS LABELLED AS 18FR ACTUALLY CONTAINED 22FR CANNULAE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONALLY, THERE WERE NO DAMAGE TO THE INTERNAL OR EXTERNAL BOXES. ALL CANNULAE PACKETS WERE SEALED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292685 ↗
• MalfunctionJun 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULAE, IT WAS REPORTED THAT THE CUSTOMER OPENED A NEW BOX OF 77422 CANNULA (LOT NUMBER: 2023020934) AND IT CONTAINED 17 PACKETS LABELLED 77422 CANNULA AND 3 PACKETS LABELLED 77418 CANNULAS. HOWEVER, THE 3 PACKETS LABELLED AS 18FR ACTUALLY CONTAINED 22FR CANNULAE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONALLY, THERE WERE NO DAMAGE TO THE INTERNAL OR EXTERNAL BOXES. ALL CANNULAE PACKETS WERE SEALED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22292654 ↗
• MalfunctionJun 19, 2025Device Markings/Labelling Problem; Device Markings/Labelling Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULAE, IT WAS REPORTED THAT THE CUSTOMER OPENED A NEW BOX OF 77422 CANNULA (LOT NUMBER: 2023020934) AND IT CONTAINED 17 PACKETS LABELLED 77422 CANNULA AND 3 PACKETS LABELLED 77418 CANNULA. HOWEVER, THE 3 PACKETS LABELLED AS 18FR ACTUALLY CONTAINED 22FR CANNULAE. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED. ADDITIONALLY, THERE WERE NO DAMAGE TO THE INTERNAL OR EXTERNAL BOXES. ALL CANNULAE PACKETS WERE SEALED INSIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22289499 ↗
• MalfunctionJun 18, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  MEDTRONIC RECEIVED INFORMATION THAT PRIOR TO USE OF A EOPA ARTERIAL CANNULA, IT WAS REPORTED THAT THE CUSTOMER OPENED A PACKAGE LABELLED 77418 18FR CANNULA BUT THE CANNULA INSIDE THE PACKAGE WAS A 22FR. THE DEVICE WAS REPLACED. THERE WAS NO PATIENT INVOLVEMENT, SO NO ADVERSE EFFECT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283913 ↗

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-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