MC3 7071Recalls & reported problems
Michigan Critical Care Consultants, Inc. · Soft Flow Aortic 18FR 6MM ANGLED BULB NON VENTED · Class 2
Data updated Oct 16, 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 10854916006727), received between Jan 29, 2020 and Jan 29, 2020 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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 16, 2026.
Most reported problems
Device problems
- Disconnection1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 29, 2020Disconnection; Disconnection
THE CUSTOMER REPORTED A MALFUNCTION TO THE DISTRIBUTOR ON 12/27/2019. THE DISTRIBUTOR FORWARDED INFORMATION ABOUT THIS MALFUNCTION ON 12/31/2019 TO MC3 INC. THE CUSTOMER DESCRIBED THE FOLLOWING: DURING THE PREPARATION FOR AN ECMO CASE USING THE MC3 SOFT FLOW ANGLED TIP ARTERIAL CANNULA, WHEN THE CANNULA WAS CLAMPED BETWEEN WIRE WINDING AND CONNECTOR, THE DEVICE SEPARATED AT THE CONNECTION OF THE CANNULA BODY AND THE CONNECTOR. AFTER THE SEPARATION OCCURRED, THE CANNULA WAS LEFT IN PLACE WITH A DIFFERENT CONNECTOR USED TO CONNECT THE CANNULA TO THE PERFUSION CIRCUIT. THE PATIENT IS ON ECMO WAITING FOR A TRANSPLANT. THERE IS NO ALLEGATION THAT THIS SEPARATION CAUSED ANY ISSUES FOR THE PATIENT. THE DEVICE WAS USED AT THE START OF THE ECMO CASE. THERE WERE NO ADVERSE PATIENT EFFECTS. THE PATIENT WAS RE-CANNULATED SO THE ORIGINAL CANNULA IS NO LONGER IN THE ECMO CIRCUIT. THE HOSPITAL DID NOT RELEASE THE CANNULA. THE MALFUNCTION OCCURRED POST CPB PROCEDURE AND DURING THE SET UP FOR THE ECMO PROCEDURE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9643843 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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