MC3 Crescent RA Dual Lumen Catheter 15FR 70415Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10850007732216), received between May 7, 2022 and Jul 30, 2025 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 30, 2025Mechanical Problem; Material Deformation; Mechanical Problem; Material Deformation

  IT WAS REPORTED THAT DURING USE THE MC3 CRESCENT 15FR RIGHT ATRIAL CANNULA WAS FOUND TO HAVE A BEND AT THE TIP OF THE CANNULA, WHICH PREVENTED THE DEVICE FROM BEING ADVANCED. THE SURGEON OPENED A NEW CANNULA AND COMPLETED THE INSERTION WITHOUT FURTHER ISSUE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22662303 ↗
• InjuryJan 12, 2023Fracture; Fracture

  ON (B)(6) 2022, AN 8 MONTH OLD PATIENT WAS CANNULATED WITH A 15 FR CRESCENT RA DUAL LUMEN CATHETER. THE PATIENT WAS DESCRIBED AS BEING VERY ACTIVE AND NOT SEDATED. ON (B)(6) 2022, THE PATIENT WAS OFF ECMO FOR A BRIEF PERIOD OF TIME DURING EXCHANGE PROCEDURE DUE TO REPORTED CATHETER FRACTURE. THE PATIENT DID NOT EXPERIENCE ANY INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16148086 ↗
• InjuryDec 22, 2022Fracture; Fracture

  ADDITIONAL INFORMATION RECEIVED INDICATED 3011468686-2022-00020 AND 3011468686-2022-00022 ARE THE SAME PATIENT. THE PATIENT, CONFIRMED TO BE 8 MONTHS OLD, WITH A HISTORY OF BRONCHOPULMONARY DYSPLASIA WAS TREATED WITH ECMO. ON (B)(6) 2022, THE PATIENT WAS INITIALLY CANNULATED. ON (B)(6) 2022 AND (B)(6) 2022, THE PATIENT WAS RE-CANNULATED THROUGH THE RIGHT IJ. THE PATIENT WAS NOT SEDATED. ON (B)(6) 2022, THE PATIENT WAS DECANNULATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16036277 ↗
• DeathMay 7, 2022Obstruction of Flow; Obstruction of Flow

  MC3 RECEIVED INFORMATION ON (B)(6) 2022 THAT DURING USE OF A 15 FR MC3 CRESCENT CATHETER AND A 15FR BIO-MEDICUS CANNULA AN ADVERSE EVENT OCCURRED ON (B)(6) 2022 DURING AN UNSUCCESSFUL ATTEMPT TO INITIATE ADEQUATE CARDIOPULMONARY SUPPORT. THE CUSTOMER REPORTED THAT THE 15 FR CRESCENT CATHETER WAS PLACED IN THE RIGHT INTERNAL JUGULAR VEIN (RIJV) PERCUTANEOUSLY. NO FLUOROSCOPY WAS USED FOR CANNULATION, INSTEAD AN ECHOCARDIOGRAM WAS PERFORMED AT THE BEDSIDE. THE CIRCUIT WAS ATTACHED TO THE CATHETERS AND RPMS INCREASED TO 2000, AND LPMS COULD NOT INCREASE HIGHER THAN 350(ML/MIN). THE CUSTOMER REPORTED THAT THE VENOUS RETURNS WERE POSITIVE, AND THE MEMBRANE PRESSURES WERE IN THE 90'S. THE SURGEON MANIPULATED THE CATHETER WITH NO CHANGE, ECHOCARDIOGRAM WAS PERFORMED AT BEDSIDE. SURGEON ADDED A 15FR BIO-MEDICUS CANNULA AND Y'D IN WITH THE MC3 CRESCENT CATHETER, THEY WERE STILL NOT ABLE TO GET FLOW. THE SVO2 REMAINED IN 90'S, ALERTING THE CUSTOMER THAT THEY WERE JUST RECIRCULATING. THE CUSTOMER STATED THAT BOTH CATHETERS WHEN UNCLAMPED HAD GREAT BLOOD RETURN AND WERE ABLE TO FLUSH. THE PATIENT BEGAN TO CODE ONCE THEY WERE UNABLE TO FLOW ADEQUATELY ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECM

  Patient problems: Respiratory Insufficiency

  MAUDE report 14331960 ↗