EOPA 3D® 78222 (UDI 20643169486250)Recalls & reported problems
Medtronic, Inc. · CANNULA 78222 EOPA 3D 22FR VNTED 10P 17L · Class 2
All models of EOPA 3D (8)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 20643169486250), received between Mar 23, 2018 and Mar 23, 2018 — classified as 1 injury.
The most frequently reported specific device problem is “Device Slipped” (1 report).
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
Device problems
- Device Slipped1
Patient problems
- Foreign Body In Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMar 23, 2018Device Slipped; Device Slipped
MEDTRONIC RECEIVED INFORMATION THAT DURING THE REMOVAL OF THIS EOPA ARTERIAL CANNULA THE SUTURE COLLAR STAYED TRAPPED IN THE AORTIC INTRAVASCULAR. THE SUTURE COLLAR THEN MIGRATED TO THE AORTOILIAC JUNCTION. THE SUTURE COLLAR WAS EXTRACTED VIA ENDOVASCULAR SURGERY. IT IS UNKNOWN WHETHER THE CUSTOMER CONTINUED TO USE THE CANNULA AFTER EXPERIENCING THIS ISSUE. THERE WERE NO OTHER ADVERSE PATIENT EFFECTS.
Patient problems: Foreign Body In Patient
MAUDE report 7366043 ↗
Other CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS devices
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- 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 HY11R00R6Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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