Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014MIBBRecalls & reported problems
Edwards Lifesciences LLC · Retrograde Cardioplegia Catheter · Class 2
Data updated Oct 18, 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 00690103034479), received between Oct 28, 2022 and Oct 28, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Nonstandard Device” (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 18, 2026.
Most reported problems
Device problems
- Nonstandard Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 28, 2022Nonstandard Device; Nonstandard Device
IT WAS REPORTED THAT THE BALLOON OF A RETROGRADE CARDIOPLEGIA CATHETER DID NOT FULLY EXPAND ON ONE SIDE OF THE CATHETER DURING CARDIAC BYPASS. THE SURGEON HAD TO SWITCH WITH ANOTHER DEVICE. NO PATIENT INJURY WAS NOTED.
Patient problems: Insufficient Information
MAUDE report 15691654 ↗
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- 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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