Cardioplegia solution administration adaptor CA-xxxxx (UDI 00803622103735)Recalls & reported problems
Livanova USA, Inc. · 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 00803622103735), received between Oct 12, 2021 and Oct 12, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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
- Fluid/Blood Leak1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 12, 2021Fluid/Blood Leak
PHYSICIAN IDENTIFIED THAT THE SUCTION DEVICE WAS LEAKING BLOOD AFTER ATTEMPTING TO PRIME THE CARDIOPLEGIA LINES AND SUCTION DEVICE. WE WERE ON BYPASS BUT HAD NOT YET CLAMPED THE AORTA.
Patient problems: Insufficient Information
MAUDE report 12614545 ↗
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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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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