EOPA™ 77622 (UDI 20763000946825)Recalls & reported problems
Medtronic, Inc. · CANNULA 77622 EOPA DIL TIP 22FR 10PK 10L · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20763000946825), received between Nov 19, 2025 and Nov 19, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 19, 2025Obstruction of Flow; Obstruction of Flow
IT WAS REPORTED THAT DURING USE OF THE EOPA ARTERIAL CANNULA THE CUSTOMER REPORTED ¿DIFFICULT LINE PRESSURES AND FLOWS.¿ THE USE OF THE DEVICE WAS CONTINUED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23591902 ↗
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, ClassifiedEOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with cardiopulmonary bypass as an arterial return cannula, Model Number 77422
- Z-2807-2026 · Jun 24, 2026 · Open, ClassifiedEOPA 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, ClassifiedEOPA 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, ClassifiedEOPA 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, ClassifiedEOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
- Z-2420-2015 · Jul 24, 2015 · TerminatedMedtronic 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
Other Catheter, cannula and tubing, vascular, cardiopulmonary bypass devices
- DLP™ 77010Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass1 recall154 reports
- EOPA™ 77422Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls19 reports
- DLP™ 77008Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls9 reports
- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.