MC3 Crescent Jugular Dual Lumen Catheter 70132Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10854916006826), received between Jan 12, 2022 and Feb 5, 2026 — classified as 3 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Material Puncture/Hole; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, IT WAS REPORTED THAT THE DEVICE HAD A BURROWED PORTION, BUT THE INFLOW HOLES. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269891 ↗
• MalfunctionJan 12, 2026Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT DURING A NEW INSERTION OF THE MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, BLOOD WAS OBSERVED LEAKING FROM THE DRAINAGE LIMB AND A CRACK WAS IDENTIFIED AT THE CONNECTOR ON THE VENOUS SIDE. THE CRACK WAS DIFFICULT TO VISUALIZE AND WAS CONFIRMED BY FLUSHING THE DEVICE WITH WATER. THE DAMAGE WAS NOT LOCATED AT THE SUTURES, AND THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED WITH ANOTHER CATHETER, WHICH FUNCTIONED PROPERLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24034604 ↗
• MalfunctionNov 26, 2025Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  IT WAS REPORTED THAT A CRACK, BREAK, OR HOLE APPROXIMATELY 2MM IN SIZE WAS IDENTIFIED JUST ABOVE THE REIN FUSION OUTLET PORT OF THE MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER DURING USE. THE DAMAGE WAS NOT LOCATED IN THE AREA OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654324 ↗
• MalfunctionJul 15, 2025Crack; Air/Gas in Device; Crack; Air/Gas in Device

  IT WAS REPORTED THAT THE CRESCENT JUGULAR DUAL LUMEN CATHETER WAS OBSERVED TO HAVE A CRACK BELOW THE GOLD WIRE REINFORCED SECTION, WITH THE CANNULA COMPLETELY CRACKED ALL THE WAY THROUGH DURING USE. AIR ENTRAINMENT WAS HEARD AFTER THE PATIENT WAS TURNED ON THEIR SIDE. THE DAMAGE WAS LOCATED IN THE AREA OF THE SUTURES. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE CATHETER REQUIRED REPLACEMENT AT THE BEDSIDE, AND EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) WAS RE-INITIATED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE NECESSARY INTERVENTION WAS TO REPLACE THE CANNULA. THE SAME SIZE CANNULA WAS PLAC ED IN THE SAME ANATOMICAL SITE AND IN THE SAME POSITION. THEY NOTICED THAT THE WHITE SUTURE RING WAS NOT USED IN THIS PROCEDURE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CANNULATION DATE WAS (B)(6) 2025. THIS WAS THE FIRST CATHETER USED IN THE CASE. THE PATIENT WAS ON ECMO FOR 17 DAYS PRIOR TO THE AIR ENTRAINMENT. THE INSERTION SITE WAS INSPECTED, CHECKED AND CLEANED DAILY AND AS PER THE NURSING SHIFT. THERE WAS NO AIR DETECTION IN THE CIRCUIT (PRE-OXY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22507370 ↗
• InjuryMay 6, 2025Break; Break

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 CRESCENT JUGULAR CATHETER, THE CUSTOMER REPORTED THAT WHILE PREPARING TO DECANNULATE THE CRESCENT CATHETER FROM THE PATIENT, CUSTOMER NOTICED THE CATHETER HAD A GURGLING SOUND. UPON VISUAL EXAMINATION THEY OBSERVED THE CRESCENT CATHETER WAS FRACTURED, THUS NECESSITATING IMMEDIATE CESSATION OF EXTRA-CORPOREAL MEMBRANE OXYGENATION (ECMO) FLOW. THE DEVICE HAD BEEN USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT IMPACT ASSOCIATED WITH THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED THAT AFTER DECANNULATION OF THE CRESCENT CATHETER, THE SURGEON PERFORMED AN EMERGENT INSERTION OF CVC WITH SWAN-GANZ CATHETER ASSISTED AIR EMBOLISM EXTRACTION DUE TO ACUTE AIR EMBOLISM SECONDARY TO CRESCENT CATHETER FRACTURE. THE PATIENT ANATOMY DID NOT CONTRIBUTE TO THE ISSUE. MEDTRONIC RECEIVED ADDITIONAL INFORMATION STATING THAT THE DEVICE WAS USED FOR 30 PLUS DAYS AND THE STANDARD INSERTION TECHNIQUE WAS PERCUTANEOUS IN THE RIGHT INTERNAL JUGULAR WAS USED.

  Patient problems: Air Embolism

  MAUDE report 21968952 ↗
• MalfunctionFeb 20, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING USE OF THE MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER THE CONNECTOR TIP ON THE VENOUS SIDE HAD VERY ROUGH EDGES, WHICH AFFECTED THE DEVICE'S PERFORMANCE. THERE WAS NO DAMAGE TO THE PACKAGING. OTHER DEVICES IN THE SAME BOX/SHIPPING CONTAINER WERE NOT DAMAGED. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21420260 ↗
• MalfunctionNov 27, 2024Material Puncture/Hole; Material Deformation; Material Puncture/Hole; Material Deformation

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A MC3 CRESCENT CANNULA, IT WAS REPORTED THAT UPON INSERTION OF 32 FR CRESCENT CANNULA THE CUSTOMER OBSERVED A CRACK AT THE RETURN PORT ROUGHLY 1-2 CM. THE CUSTOMER STATED THAT THEY BELIEVE THIS MAY HAVE BEEN CAUSED BY TORQUE OR TENSION DURING PLACEMENT AND THAT THE CANNULA COULD HAVE BEEN BENT DURING INSERTION. THE CUSTOMER STATED THAT THERE WAS NO NOTED DAMAGE TO THE PACKAGE OR CANNULA PRIOR TO INSERTION. THERE WAS NO DAMAGE AT THE LOCATION OF THE SUTURES. THERE WAS NO REPORTED BLOOD LOSS TO THE PATIENT. THE DEVICE WAS REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT DURING AN INSERTION THE CUSTOMER HAD TROUBLE WITH THE DEVICE. THE CUSTOMER WAS NOT SURE IF THE TENSION, TORQUE OR ELEMENTS WITH RESISTANCE CAUSED THE COMPROMISE AT THE PORT. THE CUSTOMER DID USE A 30 THAT WAS ALSO REMOVED, IT WAS NOT CHALLENGED. THE PATIENT WAS PLACED ON VENO-VENOUS ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VV-A ECMO), NO ISSUES WERE OBSERVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798123 ↗
• InjuryAug 14, 2024Fracture; Fracture

  MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF AN MC3 CRESCENT JUGULAR DUAL LUMEN CATHETER, IT WAS REPORTED THAT WHEN THE CUSTOMER CONNECTED THE EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) CIRCUIT TUBING, THERE WAS WHAT LOOKED TO BE A TEAR IN THE CANNULA, NEAR THE CONNECTOR. THE CUSTOMER CHANGED TO A NEW CRESCENT, BUT DURING THE EXCHANGE THE TEAR WORSENED AND EVENTUALLY BROKE OFF OUTSIDE THE PATIENT. THE PATIENT EXPERIENCED HEMORRHAGIC SHOCK DUE TO HAVING TO EXCHANGE THE CANNULA. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PROCEDURE HAD BEEN A RELATIVELY SMOOTH CANNULATION UP UNTIL THAT POINT. THE CUSTOMER'S CLAMPS WERE NEVER ON THE AFFECTED PORTION OF THE CANNULA, AND WHILE IT SEEMS THAT IT WOULD HAVE MOST LIKELY TORN DURING CONNECTION OF THE TUBING TO THE CANNULA, THE CONNECTION WAS VERY SMOOTH, AND THE PHYSICIAN DID NOT STRUGGLE TO GET IT ON OR HAVE TO DISCONNECT AND RECONNECT. THEY ONLY DISCOVERED THE TEAR AFTER UNCLAMPING THE CIRCUIT AND SUDDENLY HAVING BLOOD LEAKING. WHILE CHANGING OUT THE CANNULA, IT CONTINUED TO TEAR, SO RECANNULATING THE NEW CRESCENT WAS DELAYED. ULTIMATELY THE PATIENT WENT INTO HEMORRHAGIC SHOCK AND NEEDED BLOOD BUT SURVIVED ECMO AND WAS DECANNU

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 19981326 ↗
• InjuryJan 12, 2022Fracture; Fracture

  ECMO CANNULA (AT 50 DAYS) DEVELOPED A HAIRLINE CRACK WHICH ALLOWED AIR TO BE ENTRAINED IN THE SYSTEM. WHEN THE BUBBLE DETECTOR ALARMED THE PERFUSIONIST CONTACTED THE PHYSICIAN WHO CAME AND TOOK PATIENT TO OPERATING ROOM TO CHANGE OUT. PATIENT ARRESTED DURING THIS TIME AND SUFFERED AN ANOXIC BRAIN INJURY. WAS RESUSCITATED SUCCESSFULLY. PATIENT'S FAMILY WITHDREW CARE ON (B)(6) 2021 AND PATIENT PASSED.

  Patient problems: Brain Injury; Cardiac Arrest

  MAUDE report 13239928 ↗