Michigan Critical Care Consultants, Inc. 7072Recalls & reported problems
Michigan Critical Care Consultants, Inc. · Soft Flow Aortic Catheter 6MM Angled Bulb Vented · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10854916006369), received between May 8, 2020 and Mar 19, 2021 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Loss of or Failure to Bond” (2 reports).
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
- Loss of or Failure to Bond2
Patient problems
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 19, 2021Loss of or Failure to Bond; Loss of or Failure to Bond
DURING INSERTION OF THE CANNULA, A PARTIAL SEPARATION OF THE CANNULA FROM THE CONNECTOR WAS IDENTIFIED AT APPROXIMATELY 50% OF THE BOND. THIS OCCURRED DURING INSERTION OF THE CANNULA WHEN BLOOD WAS FILLING THE CANNULA. IT WAS NOTICED THAT THERE WAS BLOOD AROUND THE CONNECTION AND THE SURGEON DECIDED TO REMOVE THE CANNULA AND REPLACED WITH ANOTHER CANNULA OF THE SAME MODEL. THIS WAS IDENTIFIED PRIOR TO GOING ON PUMP. THERE WAS NO ADVERSE PATIENT EFFECT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11529581 ↗MalfunctionMay 8, 2020Loss of or Failure to Bond; Loss of or Failure to Bond
THE CUSTOMER REPORTED A MALFUNCTION TO THE DISTRIBUTOR. BEFORE INSERTION OF THE CANNULA, DURING SET UP OF THE PREOPERATIVE PROCEDURES, THE CONNECTION BETWEEN THE BODY AND CONNECTOR WAS INSPECTED AND FOUND TO BE LOOSE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10040088 ↗
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- DLP® Aortic Root Cannula with Flow-Guard™ 11012Medtronic, Inc. · CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS2 recalls5 reports
- 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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