Cardioplegia Pack (UDI 00803622147425)Recalls & reported problems
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 00803622147425), received between Oct 6, 2022 and Oct 6, 2022 — classified as 1 malfunction.
The most frequently reported specific device problem is “Component Misassembled” (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
- Component Misassembled1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 6, 2022Component Misassembled; Component Misassembled
LIVANOVA USA INC HAS RECEIVED A REPORT THAT THE POSITION OF THE CLAMP COLORS IN THE CARDIOPLEGIA KIT BEING USED WERE INCORRECT WHEN COMPARED WITH THE PACK SPECIFICATION SHEET. IN DETAILS, BOTH RED CLAMPS WERE ON THE SMALL TUBING SIDE AND BOTH WHITE CLAMPS ARE ON THE LARGE TUBING SIDE. ACCORDING TO THE PERFUSIONIST, AS A CONSEQUENCE, THE CONTENT OF A BAG OF HIGH POTASSIUM (K) WAS DELIVERED INTO THE RESERVOIR DESPITE HAVING BOTH WHITE CLAMPS CLOSED. THIS OCCURRED PRIOR TO THE CARDIOPULMONARY BYPASS, SO IT HAD NO IMPACT ON THE PATIENT. THERE IS NOT REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15549153 ↗
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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