Cardioplegia Pack (UDI 00803622126475)Recalls & reported problems
Data updated Oct 16, 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 00803622126475), received between Jan 11, 2019 and Jan 11, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Particulates” (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 16, 2026.
Most reported problems
Device problems
- Particulates2
Patient problems
- No Patient Involvement2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 11, 2019Particulates; Particulates
LIVANOVA RECEIVED A REPORT THAT A WHITE PARTICULATE WAS IDENTIFIED IN THE CAPPED BLUE BLOOD LINE OF THE CUSTOM PERFUSION TUBING SET DURING SETUP. THE USER WAS ABLE TO MOVE THE PARTICULATE THROUGH MANIPULATION OF THE TUBING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8240375 ↗MalfunctionJan 11, 2019Particulates; Particulates
LIVANOVA RECEIVED A REPORT THAT A WHITE PARTICULATE WAS IDENTIFIED IN THE CAPPED BLUE BLOOD LINE OF THE CUSTOM PERFUSION TUBING SET DURING SETUP. THE USER WAS ABLE TO MOVE THE PARTICULATE THROUGH MANIPULATION OF THE TUBING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 8240359 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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