Edwards Lifesciences Retrograde Cardioplegia Catheter RC2012Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00690103034370), received between Apr 1, 2022 and Sep 5, 2025 — classified as 2 injuries.

The most frequently reported specific device problem is “Burst Container or Vessel” (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

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2025Material Rupture; Material Rupture

  PER THE REPORT RECEIVED FROM FRANCE, A RC2012 RETROGRADE CANNULA, EXPERIENCED A BALLOON RUPTURE DURING CORONARY SINUS PERFUSION, APPROXIMATELY 14 MINUTES AFTER CLAMPING, IN THE CONTEXT OF AN AORTIC VALVE REPLACEMENT PROCEDURE. DESPITE PRESSURE MONITORING INDICATING NORMAL LEVELS, THE BALLOON BURST UNEXPECTEDLY, RESULTING IN A VISIBLE HERNIA AND PUNCTURE. THIS LED TO THE TERMINATION OF CORONARY INFUSION VIA THE AFFECTED CANNULA. THE RUPTURE OCCURRED WITHOUT OVERPRESSURE AND CAUSED A TEAR IN THE CORONARY SINUS. THE SURGEON SUCCESSFULLY REPAIRED THE DAMAGE USING GLUE OR SUTURES, AND PERFUSION OF THE CORONARIES WAS RESUMED USING AN ALTERNATIVE CANNULA VIA DIRECT ANTEGRADE ACCESS. THE PATIENT WAS REPORTED TO BE DOING WELL POSTOPERATIVELY.

  Patient problems: Perforation of Vessels

  MAUDE report 22975116 ↗
• InjuryApr 1, 2022Burst Container or Vessel; Burst Container or Vessel

  IT WAS REPORTED THAT THE BALLOON OF RC2012 RETROGRADE CARDIOPLEGIA CANNULA RUPTURED DURING USE WITH A CONCOMITANT RUPTURE OF THE PATIENT'S CORONARY SINUS OCCURRED. THE CANNULA WAS INSERTED TO THE CORONARY SINUS AND THE CARDIOPLEGIA SOLUTION WAS INJECTED. AT FIRST, THE CORONARY SINUS PRESSURE WAS INDICATED AS 20MMHG, HOWEVER THE PRESSURE WENT DOWN TO A SINGLE DIGIT LEVEL. THE CANNULA WAS REMOVED, AND THE BALLOON RUPTURE WAS CONFIRMED THEN. AT THE SAME TIME, THE PATIENT CORONARY SINUS WAS ALSO CONFIRMED TO BE RUPTURED. THE PATIENT CORONARY SINUS WAS REPAIRED AND ANOTHER RC2012 RETROGRADE CARDIOPLEGIA CANNULA WAS USED. THE SURGERY WAS COMPLETED, AND THE PATIENT STATUS WAS REPORTED AS 'UNDER TREATMENT'. THERE WAS NO CALCIFICATION OF CORONARY SINUS. THE FLOW RATE OF CARDIOPLEGIC SOLUTION WAS 200 ML/MIN, BUT THE INJECTION PRESSURE DID NOT RISE, SO THE FLOW RATE WAS RISEN TO 300ML/MIN. THE CANNULA WAS INSERTED WHEN THE PATIENT WAS PARTIALLY ON CARDIOPULMONARY BYPASS. THE LOCATION OF THE TIP OF THE CANNULA WAS CORRECT AS THE SURGEON WAS PLACING HIS HAND TO THE PATIENT'S HEART AND CHECKING IT BY THE ECHO. BALLOON INFLATION TEST BEFORE USE WAS PROBABLY NOT PERFORMED. INCONSISTENCIES OF THE D

  Patient problems: Perforation of Vessels

  MAUDE report 13981088 ↗