Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014MRecalls & 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 00690103034455), received between Jul 8, 2025 and Jul 8, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
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.
MalfunctionJul 8, 2025Fracture; Fracture
IT WAS REPORTED THAT THE PART A FEW MILLIMETERS FROM THE TIP OF A RC2014M RETROGRADE CANNULA GOT FRACTURED DURING SURGERY. AT THE DEVICE REMOVAL, THE FRACTURED TIP CAME OFF. AT FIRST AT THE PROCEDURE, ANTEGRADE CARDIOPLEGIA OF A NON-EDWARDS DEVICE WAS USED ONCE FOR MYOCARDIAL PROTECTION, HOWEVER, DUE TO AORTIC REGURGITATION, THE APPROPRIATE AMOUNT COULD NOT BE DELIVERED, SO THEN THE RETROGRADE CARDIOPLEGIA RC2014M WAS USED. MYOCARDIAL PROTECTION WAS DELIVERED THREE TIMES SUCCESSFULLY. THE CANNULA WAS FUNCTIONAL UP UNTIL THEN. WHEN ATTEMPTING THE FOURTH DELIVERY, THE PRESSURE WENT HIGH -AROUND 300 MMHG- THEREFORE THE CANNULA WAS REMOVED. THE PART A FEW MILLIMETERS FROM THE TIP WAS FRACTURED AND ABOUT TO COME OFF, AND WHEN THE DEVICE WAS REMOVED, THE TIP CAME OFF. DURING THE SIMULTANEOUS MAZE PROCEDURE, CRYOICE WAS USED ON THE LEFT ATRIUM, WHICH LED TO A HIGH-PRESSURE SITUATION. FLOW RATE DURING BALLOON INFLATION WAS 200ML PER M. CORONARY SINUS PRESSURE WAS 30 TO 35 MMHG. PEAK PRESSURE WAS 300MMHG. THE PLACEMENT POSITION OF THE CANNULA TIP WAS APPROPRIATE. VISUAL INSPECTION AND INFLATION TEST BEFORE USE WAS NOT PERFORMED. CRYOICE WAS DONE PRIOR TO MVR. AFTER THE DEVICE WAS REMOVED AN
Patient problems: Insufficient Information
MAUDE report 22437658 ↗
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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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