Cardioplegia Pack (UDI 00803622119880)Recalls & reported problems
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00803622119880), received between Jan 10, 2024 and Nov 28, 2024 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Misassembled” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Misassembled2
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 28, 2024Misassembled; Misassembled
LIVANOVA RECEIVED A REPORT ABOUT WHITE AND RED CLAMPS WERE PLACED ON THE WRONG LINES DISCOVERED DURING PRIMING BY PERFUSIONIST. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20804065 ↗MalfunctionNov 27, 2024Misassembled; Misassembled
LIVANOVA RECEIVED A REPORT ABOUT THE RED AND WHITE "ROBERTS" CLAMPS WHERE PUT ON THE WRONG LINES DURING ASSEMBLY. THE RED WERE PLACED WHERE THE WHITE SHOULD BE AND THE WHITE WERE PLACED WHERE THE RED SHOULD BE. THIS HAS OCCURRED ON THREE PACKS IN THE SAME LOT NUMBER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20794781 ↗MalfunctionJan 10, 2024Component Misassembled; Component Misassembled
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18481983 ↗
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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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