MC3 Crescent RA Dual Lumen Catheter 13FR 70413Recalls & reported problems
Michigan Critical Care Consultants, Inc. · The Jugular Dual Lumen Catheter is a single use dual lumen catheter, which provides both venous drainage and reinfusion of blood via the jugular vein, that is indicated for use in adult and pediatric patients with acute respiratory failure requiring VenoVenous Extracorporeal Membrane Oxygenation where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10850007732209), received between Apr 23, 2024 and Apr 23, 2024 — classified as 1 death.
The most frequently reported specific device problem is “Crack” (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.
Reports received per month
Most reported problems
Device problems
- Crack1
Patient problems
- Insufficient Information1
- Reduced Blood Flow1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathApr 23, 2024Crack; Crack
ON (B)(6) 2024, A FEMALE NEWBORN (36 HOURS OLD, WEIGHT 3.4 KG), 38 WEEK DELIVERY WITH MECONIUM ASPIRATION, WAS CANNULATED WITH A CRESCENT RA 13 FR CATHETER TO THE IJ USING AN OPEN CUT-DOWN TECHNIQUE. THE PATIENT WAS PARALYZED AND SEDATED. APPROXIMATELY 5 MINUTES AFTER ECMO WAS INITIATED, A CRACK WAS NOTICED JUST BELOW THE GOLD SUTURE RING CAUSING AIR ENTRAINMENT AND THE INABILITY TO FLOW THROUGH THE ECMO CIRCUIT. SUTURES WERE PRESENT ON THE CANNULA BODY. IT WAS REPORTED THAT A NEW CATHETER WAS UNABLE TO BE PLACED DUE TO THE SURGEON BEING UNABLE TO PUSH A SECOND CATHETER PAST 4 CM SUCH THAT THE ECMO THERAPY WAS NOT CONTINUED. THE PATIENT WAS REPORTED AS DECEASED. DATE OF DEATH IS (B)(6) 2024. CAUSE OF DEATH IS UNKNOWN.
Patient problems: Insufficient Information; Reduced Blood Flow
MAUDE report 19168442 ↗
Other Dual Lumen Ecmo Cannula devices
- MC3 Crescent Jugular Dual Lumen Catheter 70132Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula9 reports
- MC3 Crescent Jugular Dual Lumen Catheter 70128Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula5 reports
- MC3 Crescent RA Dual Lumen Catheter 15FR 70415Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 death4 reports
- MC3 Crescent Jugular Dual Lumen Catheter 70130Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent(tm) Jugular Dual Lumen Catheter 70128Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent Jugular Dual Lumen Catheter 70126Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- MC3 Crescent Jugular Dual Lumen Catheter 70124Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 report
- PROTEK DUO+ 5150-5131Sorin Group Italia Srl · Dual lumen ECMO cannula1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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