Perfusion Pack (UDI 00803622142840)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 00803622142840), received between Dec 6, 2019 and Dec 6, 2019 — 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 Patient Involvement1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 6, 2019Misassembled; Misassembled
LIVANOVA USA IN HAS RECEIVED A REPORT THAT, DURING THE TEST BEFORE INITIATING THE PROCEDURE, IT WAS FOUND THAT THE ARTERIAL AND THE VENOUS LINES WERE SWAPPED THEY RECTIFIED IT BY SWITCHING THE 3/8" TUBING ON THE ARTERIAL AND VENOUS CANNULAS. THE ISSUE OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 9422668 ↗
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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