Perfusion Pack (UDI 00803622157493)Recalls & reported problems
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622157493), received between Dec 11, 2025 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Obstruction of Flow” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Obstruction of Flow1
- Pumping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Obstruction of Flow
Upon initiation of bypass, it was visualized that the blood draining from the venous line was collecting in the sock filter of the reservoir rather than draining into the main body of the reservoir. The surgeon was notified. This hold-up resolved as the bypass run continued.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945167 ↗MalfunctionDec 11, 2025Pumping Problem; Pumping Problem
SORIN GROUP ITALIA RECEIVED A REPORT OF A REVOLUTION PUMP WHICH COULD NOT PROVIDE PROPER FLOW WHEN INCREASING ROUNDS PER MINUTES (RPMS), AND LOW PRESSURE WAS HIGHLIGHTED AT INLET PUMP LINE. THE ISSUE OCCURRED DURING PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23776508 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.