MC3 Crescent(tm) Jugular Dual Lumen Catheter 70128Recalls & reported problems
Michigan Critical Care Consultants, Inc. · Jugular Dual Lumen Catheter 28 Fr · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10854916006932), received between Sep 19, 2020 and Sep 19, 2020 — classified as 1 injury.
The most frequently reported specific device problem is “Fracture” (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
- Fracture1
Patient problems
- Air Embolism1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 19, 2020Fracture; Fracture
THE PATIENT WAS SUPPORTED ON ECMO SINCE (B)(6) WITH EXTRACORPOREAL CIRCUIT INCLUDING SUBJECT CATHETER DEVICE FOR 53 DAYS. ON (B)(6), WHEN NURSES WERE TURNING PATIENT OVER AND RE-POSITIONING PATIENT , AIR STARTED ENTERING THE ECMO CIRCUIT. THE CLINICIANS COULD NOT FIND WHERE AIR WAS COMING FROM. THE CLINICIANS ATTEMPTED TO DE-AIR THE CIRCUIT, BUT AIR STILL ENTERED. PATIENT WAS TAKEN OFF ECMO SUPPORT AND THEN 40 MINUTES LATER THE PATIENT DIED, AFTERWARDS, THE CLINICIANS INSPECTED THE CATHETER AND FOUND A CRACK RIGHT ALONG ONE OF THE BLACK LINES BELOW GOLD SUTURE AREA. THIS WAS THE SUSPECTED LOCATION WHERE THE AIR ENTERED THE CIRCUIT.
Patient problems: Air Embolism
MAUDE report 10557789 ↗
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 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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