MC3 Crescent Jugular Dual Lumen Catheter 70128Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10854916006802), received between Feb 7, 2022 and Dec 11, 2025 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Air/Gas in Device” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Material Deformation; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, IT WAS REPORTED THAT THERE WERE SIGNS OF KINKING ON THE STEEL WIRE AT THE OPENING OF THE PRODUCT PERFUSION PORT.THE USE OF THE DEVICE WAS UNKNOWN. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23775876 ↗
• InjuryMay 30, 2025Crack; Air/Gas in Device; Crack; Air/Gas in Device

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, IT WAS REPORTED THAT THE DEVICE HAD A CRACK, AND AIR BUBBLES WERE SEEN. THE PATIENT HAD BEEN ON CRESCENT SUPPORT FOR 3 MONTHS AND THEY WERE MOBILE (WALKING). AIR WAS SPONTANEOUSLY NOTED IN THE CANNULA. THE PATIENT WAS DECANNULATED AS A RESULT. THE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS CANNULATED THROUGH THE RIGHT INTERNAL JUGULAR (RIJ) VEIN. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT WAS TURNED FOR A CLEAN-UP. CENTRIMAG BEGAN REVEALED THAT THERE WAS NO FLOW BUT DASHES. THE PERFUSION AND ECMO (EXTRACORPOREAL MEMBRANE OXYGENATION) COORDINATORS WERE CALLED. THE PERFUSION SWITCHED THE CENTRIMAG PROBES. AIR OR BLOOD MIXED WITH AIR WAS TO BE OBSERVED IN THE VENOUS LINE AND ACCUMULATING IN THE OXYGENATOR. THE VENOUS LINE WAS NOT CLAMPED DUE TO THE PERFUSION STATING THAT IT WAS VV (VENO-VENOUS) ECMO AND THAT THERE WAS NOT A LARGE AMOUNT OF AIR TRAVELLING TO THE PATIENT. ULTIMATELY, THEY OBSERVED THAT THE PATIENT'S ECMO CANNULA WAS CRACKED AND CAUSING A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22113342 ↗
• InjuryMar 29, 2023Use of Device Problem; Air/Gas in Device; Use of Device Problem; Air/Gas in Device

  THIS IS A FOLLOW UP TO THE PREVIOUS REPORT 3011468686-2023-00004. ADDITIONAL INFORMATION INDICATED THE PATIENT'S WEIGHT WAS 78.3 KG. ON (B)(6) 2022, THE PATIENT WAS CANNULATED IN THE RIGHT INTERNAL JUGULAR WITH A 32 FR CRESCENT CATHETER. ON (B)(6) 2022 AT 1453, THE PATIENT WAS WEANED OFF ECMO AND DECANNULATED. ON (B)(6) 2022, THE PATIENT DECOMPENSATED. AT 1802 THE PATIENT WAS RE-CANNULATED IN THE RIGHT SUBCLAVIAN WITH A 28 FR CRESCENT CATHETER (PREVIOUSLY REPORTED AS A 32 FR CATHETER) UTILIZING A SELDINGER TECHNIQUE AND ECMO WAS REINITIATED FOR THE TREATMENT OF DECOMPENSATED RESPIRATORY FAILURE. THE CATHETER WAS PLACED UNDER FLUOROSCOPIC GUIDANCE AND WAS SECURED IN PLACE WITH MULTIPLE 0 ETHIBOND SUTURES TO PREVENT MIGRATION. STERILE DRESSINGS WERE APPLIED. ON (B)(6) 2022 (PREVIOUSLY REPORTED AS (B)(6) 2023), THE CATHETER WAS REPLACED WITH A 28 FR CRESCENT CATHETER TO THE RIGHT INTERNAL JUGULAR DUE TO AIR ENTRAINMENT FROM AN UNKNOWN SOURCE. ON (B)(6) 2023, THE PATIENT WAS RESTLESS. CHEST X-RAY CONFIRMED CATHETER MIGRATION. IT WAS REPORTED THE CATHETER WAS SECURED IN FOUR LOCATIONS TO THE PATIENT. THE CATHETER WAS REPLACED WITH A 28 FR CRESCENT CATHETER IN THE RIGHT INTERNAL JUGULAR.

  Patient problems: Low Oxygen Saturation

  MAUDE report 16637748 ↗
• MalfunctionJul 25, 2022Break; Break

  AFTER DECANNULATION OF THE CRESCENT CATHETER, THE PERFUSIONIST NOTICED A SMALL FRACTURE JUST BENEATH THE GOLD SUTURE RING. THERE WAS NO EFFECT TO THE PATIENT NOR ANY ADDITIONAL INTERVENTIONS PERFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15093025 ↗
• InjuryFeb 7, 2022Positioning Problem; Positioning Problem

  MC3 RECEIVED INFORMATION THAT A (B)(6) BOY WAS BEING PUT ON VV ECMO SUPPORT WHEN THE CATHETER BECAME STUCK AND BROKE OFF. THE PATIENT WAS TRANSPORTED TO THE OPERATING ROOM AND IT WAS DETERMINED THAT THE BROKEN PIECE OF THE CATHETER WAS FIRMLY STUCK BEHIND THE CLAVICLE IN THE INTERNAL JUGULAR VEIN. ATTEMPTS TO EXTRACT THE CATHETER REVEALED THAT IT WAS ENTANGLED WITH THE PICC LINE. PATIENT WAS TAKEN TO INTERVENTIONAL RADIOLOGY AND THE DECISION WAS MADE TO PROCEED WITH A STERNOTOMY. THE CATHETER TIP WAS ABLE TO BE REMOVED AND THE PATIENT WAS TRANSFERRED BACK TO PEDIATRIC INTENSIVE CARE.

  Patient problems: Hematoma; Swelling/ Edema

  MAUDE report 13475132 ↗