Perfusion Pack (UDI 00803622147814)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 00803622147814), received between Oct 21, 2021 and Oct 21, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Disconnection” (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
- Disconnection1
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.
MalfunctionOct 21, 2021Disconnection; Disconnection
LIVANOVA USA INC HAS RECEIVED A REPORT THAT, DURING A BYPASS, THE QUICK CONNECTORS BETWEEN THE OUTLET OF THE REVOLUTION PUMP AND THE INLET OF THE OXYGENATOR DISCONNECTED. THE QUICK CONNECTORS WERE PROVIDED ALREADY TIE BANDED. THE PATIENT WAS TRANSFUSED WITH BLOOD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12672320 ↗
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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