Michigan Critical Care Consultants, Inc. 6384Recalls & reported problems
Michigan Critical Care Consultants, Inc. · Soft Flow Aortic Catheter, Angled Tip Flange 8MM NON VENTED · 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 10854916006260), received between Jan 22, 2020 and Jan 22, 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 18, 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 22, 2020Disconnection; Disconnection
THE MALFUNCTION OCCURRED ON (B)(6) 2019 AND WAS REPORTED TO THE DISTRIBUTOR BY THE CUSTOMER. THE DISTRIBUTOR FORWARDED INFORMATION ABOUT THIS MALFUNCTION ON (B)(6) 2019 TO MC3. THE CUSTOMER DESCRIBED THE FOLLOWING: AT THE END OF A CARDIOPULMONARY BYPASS SURGERY, WHEN THEY WERE REMOVING THE MC3 SOFT FLOW ANGLED TIP ARTERIAL CANNULA , IT WAS NOTED THAT THE CANNULA BECAME UNBONDED. THE DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PATIENT EFFECTS.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9617773 ↗
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- EOPA™ 77622Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls4 reports
- NA HY2V10R33Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls3 reports
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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