Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014SRecalls & 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
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00690103034486), received between Feb 7, 2025 and Feb 7, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Mechanical Problem” (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.
Reports received per month
Most reported problems
Device problems
- Mechanical Problem1
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.
MalfunctionFeb 7, 2025Mechanical Problem; Mechanical Problem
EDWARDS WAS NOTIFIED OF A COMPLAINT FROM A CUSTOMER STATING SUCTION TIP BROKE DURING A PROCEDURE. THE TIP WAS REPORTED TO HAVE COME OFF IN THE CHEST CAVITY OF THE PATIENT. THE TIP WAS RETRIEVED AND CONFIRMATION OF REMOVAL OF PIECES WAS COMPLETED BY THE SURGICAL STAFF. THE FAILURE WAS REPORTED TO BE WITH RC2014S FROM LOT 2023051119. THE DEVICE IS NOT AVAILABLE FOR RETURN. PATIENT IMPACT AND STATUS ARE UNKNOWN. THIS EVENT WAS REPORTED TO THE FDA AS MDR-30 DAY REPORTABLE WITH REFERENCE NUMBER (B)(4) IN RELATION TO THE DISTRIBUTOR KIT MODEL DYNJ76106C CABG-PUMP-LF WHICH INCLUDES THE RC2014S. REPORT MW5159684 IS REFERENCED AS PART OF THAT REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Insufficient Information
MAUDE report 21339755 ↗
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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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