enableCV ProPlege Peripheral Retrograde Cardioplegia Device PR9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00840479400013), received between Feb 26, 2026 and May 14, 2026 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K120780); they may or may not involve this specific model.

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.

• MalfunctionMay 14, 2026Infusion or Flow Problem

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH A PROPLEGE DEVICE. THE DEVICE PLACEMENT WENT AS PLANNED AND THE ANESTHESIOLOGIST WAS SATISFIED WITH THE POSITION OF THE CATHETER IN CORONARY SINUS. SURGEON APPLIED A CROSS CLAMP TO THE ASCENDING AORTA AND ASKED FOR DELIVERY OF RETROGRADE CARDIOPLEGIA IN ORDER TO ARREST THE HEART. DELIVERY BEGAN WITH LINE PRESSURE GOING UP TO APPROXIMATELY 175 MMHG AND FLOW RATE OF APPROXIMATELY 60 ML/MIN. SINUS PRESSURE INCREASED TO APPROXIMATELY 35-37 MMHG. ARREST WAS NOT ACHIEVED. RETROGRADE CARDIOPLEGIA DELIVERY WAS STOPPED. THE ANESTHESIOLOGIST SUSPECTED THAT THE CATHETER MIGHT BE IN TOO DEEP SO HE DEFLATED THE BALLOON AND PULLED BACK APPROXIMATELY 2 CM. RETROGRADE DELIVERY WAS RESUMED WITH THE SAME PRESSURE AND FLOW READINGS NOTED ABOVE. THE PERFUSIONIST INCREASED LINE PRESSURE TO 175 MMHG AS NOTED AND THE SINUS PRESSURE INCREASED TO 40 MMHG, THEN 60 MMHG AND FINALLY 80 MMHG. LINE PRESSURE WAS DIALED DOWN AND SINUS PRESSURE DECREASED TO APPROXIMATELY 35 MMHG. ARREST WAS NOT ACHIEVED. RETROGRADE DELIVERY WAS DISCONTINUED. THE ANESTHESIOLOGIST REPEATED THE STEPS TO DEFLATE THE BALLOON AND BULLED BACK ANOTHER 2 CM. AFTER RE-INFLATION, RETROGRADE DELIVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25179209 ↗
• InjuryFeb 26, 2026Use of Device Problem

  DURING THE PLACEMENT OF THE DEVICE IT WAS NOT VISUALIZED ON THE TEE IN THE TWO CHAMBER VIEW. THE TEAM WAS LOOKING AT THE DEPTH MARKERS INSTEAD AND FELT THEY WERE DEEP ENOUGH EVEN THOUGH THEY DID NOT SEE THE TIP OF THE DEVICE ON TEE. WHILE THIS WAS NOT VISUALIZED, THE BALLOON WAS INFLATED SLOWLY BY 0.1 ML INTERVALS. THIS WAS AN ERROR IN DEVICE USE PER THE IFU AS THEY SHOULD HAVE WAITED TO INFLATE AFTER CONFIRMING VISUALIZATION OF PLACEMENT PER THE TEE. THIS CORONARY SINUS APPEARED LARGE IN THE 2 CHAMBER VIEW AND THE BALLOON WAS INFLATED TO ACHIVE VENTRICULARIZATION SLOWLY UNTIL 1.0ML. NO VENTRICULARIZATION WAS NOTED ON THE VITALS, AND THE VOLUME WAS REMOVED AND THE DEVICE BROUGHT BACK TO THE BICAVAL VIEW. UPON RETRACTION OF THE DEVICE THE PATIENT'S HEMODYNAMICS BECAME UNSTABLE AND IT WAS DETERMINED THAT THE CORONARY SINUS HAD BEEN RUPTURED. PER ADDITIONAL INFORMATION, BICAVAL VIEW WAS STEP 1. THEY WERE WORRIED ABOUT PLACEMENT. THEN THEY STARTED RETRACTING IT. WHEN ASKED ABOUT RESISTANCE, THE REP REPORTED THAT THE DEVICE WAS MOVING THROUGH THE SHEETH AND VASCULATURE SMOOTHLY WITHOUT RESISTANCE. THE INJURY POTENTIALLY OCCURRED DURING PLACEMENT/ INFLATION. CASE WAS A MYXOMA. THE PATIEN

  Patient problems: Hemodynamic instability; Perforation of Vessels

  MAUDE report 24464690 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K120780. One submission often covers many models, so check the product and lot details in each record.

• Z-1322-2013 · Jan 25, 2013 · Terminated
  Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circul