MC3 Crescent Jugular Dual Lumen Catheter 70130Recalls & 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 10854916006819), received between Feb 24, 2022 and Feb 24, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Material Protrusion/Extrusion” (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.
Most reported problems
Device problems
- Material Protrusion/Extrusion1
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.
MalfunctionFeb 24, 2022Material Protrusion/Extrusion; Material Protrusion/Extrusion
THE DISTRIBUTOR, (B)(4), REPORTED A COMPLAINT FROM A CUSTOMER WHO REPORTED THIS INFORMATION TO MC3. THE CUSTOMER HAD A PATIENT ON VENO-VENOUS ECMO FOR 60 DAYS AND THEN DID A PLANNED CATHETER EXCHANGE. THERE WAS NO DIRECT PATIENT IMPACT. UPON LOOKING AT THE CATHETER AFTER THE CATHETER WAS EXCHANGED, THE CUSTOMER NOTICED THAT THERE WAS SOME EXPOSURE OF THE WIRE ON THE CATHETER. THE CUSTOMER REPORTED THAT THEY DID NOT USE THE PROVIDED SUTURE COLLAR BUT STATED THEY SUTURED ON THE GOLD RING. THEY STATED THAT THEY USE A VELCRO HEAD WRAP TO SECURE THE CATHETER TO THE PATIENT. THE INFORMATION STATED THAT THEY TRY TO AMBULATE THE PATIENT AND THERE IS SOME MANIPULATION OF THE LINES AND CATHETER OVER TIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13592942 ↗
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(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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