Perfusion Pack (UDI 00803622132759)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 00803622132759), received between Feb 21, 2019 and Feb 21, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Crack” (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
- Crack1
Patient problems
- Death1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 21, 2019Crack; Crack
LIVANOVA USA INC HAS RECEIVED VIA THE U.S. MAIL THE MEDWATCH REPORT # (B)(4) STATING THAT, DURING A PROCEDURE, WHILE APPLYING THE STOPCOCK/LUER LOCK OF THE INLET LINE OF THE RIGHT VENTRICULAR ASSIST DEVICE (RVAD) TO INFLOW CANNULA, THERE WAS AN AUDIBLE CRACKING SOUND AND AIR WAS BEING ENTRAINED. THE PATIENT DIED.
Patient problems: Death
MAUDE report 8358210 ↗
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