CBCII Consta Vac 0225414000Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04546540867605), received between Sep 7, 2018 and Aug 8, 2019 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

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.

• MalfunctionAug 8, 2019Infusion or Flow Problem; Infusion or Flow Problem

  THE USER FACILITY REPORTED THE DEVICE STOPPED WORKING AFTER 50-100 ML OF BLOOD WAS COLLECTED. THERE WERE NO ADVERSE CONSEQUENCES, NO DELAY AND NO MEDICAL INTERVENTION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8877073 ↗
• InjurySep 7, 2018Break; Break

  THE USER FACILITY REPORTED THAT THE PART OF THE DRAIN WAS LEFT INSIDE THE PATIENT AFTER A PROCEDURE. A REVISION SURGERY WAS COMPLETED WITHOUT ANY FURTHER COMPLICATIONS OR MEDICAL INTERVENTION NEEDED FOR THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7857124 ↗