MC3 Crescent Jugular Dual Lumen Catheter 70124Recalls & reported problems
Michigan Critical Care Consultants, Inc. · Dual Lumen ECMO Cannula · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10854916006789), received between Nov 27, 2024 and Nov 27, 2024 — classified as 1 malfunction.
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
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 27, 2024Crack; Crack
MEDTRONIC RECEIVED INFORMATION THAT DURING INSERTION OF AN MC3 CRESCENT CANNULA, IT WAS REPORTED THAT THE CONNECTOR ON THE RETURN CONNECTION WAS CRACKED. THE HEMOSTASIS CAP WAS USED WHEN THE INTRODUCER WAS INSERTED INTO THE CANNULA BODY CONNECTOR. THE RETURN (ARTERIAL) CONNECTOR WAS CUT OUT AND REPLACED WITH ANOTHER 3/8X3/8 STRAIGHT CONNECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER STATED THIS WAS AN URGENT CANNULATION. THE PATIENT WAS WEANED FROM SUPPORT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE EXACT LOCATION OF THE CRACK ON THE CANNULA WAS ON THE ARTERIAL (RETURN) SIDE OF THE CANNULA. THE CRACK WAS NOTICED ON INSERTION INTO THE PATIENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER STATED THAT THE CONNECTOR WAS CRACKED ON THE CONNECTOR GLUE JOINT SIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20798137 ↗
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 RA Dual Lumen Catheter 13FR 70413Michigan Critical Care Consultants, Inc. · Dual Lumen Ecmo Cannula1 death1 report
- 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
- 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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