Cardioplegia solution administration adaptor CA-xxxxx (UDI 00803622103650)Recalls & reported problems
Livanova USA, Inc. · 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 00803622103650), received between Oct 11, 2016 and Oct 11, 2016 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak2
- Increase in Pressure2
- No Flow2
Patient problems
- Blood Loss2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 11, 2016Fluid/Blood Leak; Increase in Pressure; No Flow; Fluid/Blood Leak; Increase in Pressure; No Flow
SORIN GROUP RECEIVED A REPORT THAT THE CARDIOPLEGIA ADAPTER CANNULA WAS BLOCKED AND CAUSED OVER-PRESSURIZATION AND BLOOD LEAKAGE DURING A PROCEDURE. THE DEVICE WAS SWITCHED OUT TWICE, AND THE ISSUE RECURRED BOTH TIMES. ON THE THIRD OCCURRENCE, THE USER NOTICED THAT THE Y-CONNECTOR WAS BLOCKED. THE PATIENT LOST A SIGNIFICANT AMOUNT OF BLOOD, AND THE PROCEDURE WAS EXTENDED BY 40 MINUTES.
Patient problems: Blood Loss
MAUDE report 6018809 ↗MalfunctionOct 11, 2016Fluid/Blood Leak; Increase in Pressure; No Flow; Fluid/Blood Leak; Increase in Pressure; No Flow
SORIN GROUP RECEIVED A REPORT THAT THE CARDIOPLEGIA ADAPTER CANNULA WAS BLOCKED AND CAUSED OVER-PRESSURIZATION AND BLOOD LEAKAGE DURING A PROCEDURE. THE DEVICE WAS SWITCHED OUT TWICE, AND THE ISSUE RECURRED BOTH TIMES. ON THE THIRD OCCURRENCE, THE USER NOTICED THAT THE Y-CONNECTOR WAS BLOCKED. THE PATIENT LOST A SIGNIFICANT AMOUNT OF BLOOD, AND THE PROCEDURE WAS EXTENDED BY 40 MINUTES.
Patient problems: Blood Loss
MAUDE report 6018807 ↗
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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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