Perfusion Pack (UDI 00803622130342)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00803622130342), received between Mar 24, 2017 and Mar 24, 2017 — classified as 2 deaths.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• DeathMar 24, 2017Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP RECEIVED A REPORT OF A LEAK FROM THE "PRONTO" LINE OF THE CUSTOMER PERFUSION TUBING SET, WHICH RESULTED IN APPROXIMATELY 2L OF BLOOD LOSS. THE HOSPITAL REPORTED THAT THE PATIENT HAD A STROKE THE DAY AFTER THE PROCEDURE AND LATER EXPIRED. IT IS UNKNOWN IF THE STROKE OR DEATH ARE RELATED TO THE REPORTED LEAK.

  Patient problems: Blood Loss; Death; Stroke/CVA

  MAUDE report 6433016 ↗
• DeathMar 24, 2017Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP RECEIVED A REPORT OF A LEAK FROM THE "PRONTO" LINE OF THE CUSTOMER PERFUSION TUBING SET, WHICH RESULTED IN APPROXIMATELY 2L OF BLOOD LOSS. THE HOSPITAL REPORTED THAT THE PATIENT HAD A STROKE THE DAY AFTER THE PROCEDURE AND LATER EXPIRED. IT IS UNKNOWN IF THE STROKE OR DEATH ARE RELATED TO THE REPORTED LEAK.

  Patient problems: Blood Loss; Death; Stroke/CVA

  MAUDE report 6432989 ↗