Cardioplegia solution administration adaptor CA-xxxxx (UDI 00803622103797)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 00803622103797), received between Jan 10, 2024 and Nov 25, 2024 — classified as 2 malfunctions.
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.
Reports received per month
Most reported problems
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 25, 2024
DURING THE PROCEDURE A LIVANOVA CARDIOPLEGIA ADAPTER WAS USED. WHEN STARTING TO USE THE DEVICE, IT BEGAN TO LEAK AND THEN AIR WAS NOTICED TO BE IN THE SYSTEM. UPON OBSERVATION, NEAR TWO OF THE CONNECTION ON THE DEVICE HAD TEARS/CUTS IN THE TUBING UNDER THE SCREW HUBS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20770997 ↗MalfunctionJan 10, 2024
THE CP BYPASS MACHINE WAS UNABLE TO FLOW THROUGH THE DELIVERY DEVICE LIVA NOVA CARDIOPLEGIA ADMINISTRATION ADAPTOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18484332 ↗
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- NA HY11W65R1Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls8 reports
- DLP® 12113Medtronic, Inc. · Catheter, cannula and tubing, vascular, cardiopulmonary bypass2 recalls6 reports
- 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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