Edwards Lifesciences Retrograde Cardioplegia Catheter RC2014LBRecalls & 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 00690103034424), received between Oct 25, 2024 and Oct 25, 2024 — classified as 1 injury.
The most frequently reported specific device problem is “Material Too Rigid or Stiff” (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
- Material Too Rigid or Stiff1
Patient problems
- Sinus Perforation1
- Unspecified Tissue Injury1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 25, 2024Material Too Rigid or Stiff; Material Too Rigid or Stiff
EDWARDS RECEIVED NOTIFICATION OF A PATIENT INJURY THAT RESULTED IN A MEDICAL EMERGENCY DURING THE USE OF THE 14FR RETROGRADE CANNULA RC 2014 LB. REPORTEDLY, THE INJURY WAS CAUSED BY AN UNEXPECTED INCREASE IN STIFFNESS IN THE CATHETER MATERIAL, PARTICULARLY AT THE TIP, THAT LED TO THE SURGEON, WHO WAS NOT FAMILIAR WITH THE MATERIAL BEING HARDER THAN IT USED TO BE, INADVERTENTLY CAUSING THE INJURY.
Patient problems: Sinus Perforation; Unspecified Tissue Injury
MAUDE report 20531280 ↗
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- 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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