Perfusion Pack (UDI 00803622138218)Recalls & reported problems
All models of Perfusion Pack (77)
Data updated Oct 16, 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 00803622138218), received between Apr 23, 2020 and Apr 23, 2020 — 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 16, 2026.
Most reported problems
Device problems
- Misassembled1
Patient problems
- No Consequences Or Impact To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2020Misassembled; Misassembled
LIVANOVA USA INC HAS BEEN INFORMED THAT, DURING A PROCEDURE, THE MEDICAL TEAM IDENTIFIED THAT TUBING OF THE DELNIDO CARDIOPLEGIA CIRCUIT WERE SWAPPED WITH THE RESPECT TO THE TECHNICAL DRAWING. THIS CAUSED THE PATIENT TO RECEIVE THE INCORRECT AMOUNT OF CARDIOPLEGIA DOSE. THERE IS NO REPORT OF ANY PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9989287 ↗
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.
How reports and recalls are matched · Editorial policy · Report an error on this page