Perfusion Pack (UDI 00803622148255)Recalls & reported problems
All models of Perfusion Pack (77)
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 00803622148255), received between Aug 1, 2023 and Aug 1, 2023 — classified as 1 malfunction.
The most frequently reported specific device problem is “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
- 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.
MalfunctionAug 1, 2023Misassembled; Misassembled
LIVANOVA USA INC RECEIVED A REPORT THAT THE CARDIOPLEGIA LINES IN THE CARDIOPLEGIA CIRCUIT WERE REVERSED. THE ISSUE WAS IDENTIFIED DURING BYPASS. MEDICAL TEAM ELCTED TO ADIMINISTER ADDITIONAL CARDIOPLEGIA DOSE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17434700 ↗
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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