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CBCII ConstaVac 0225028000ERecalls & reported problems

Stryker Corporation · Blood Conservation System · Class 2

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 04546540867131), received between Aug 15, 2018 and Aug 15, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Infusion or Flow Problem” (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

Device problems

  • Infusion or Flow Problem1

Patient problems

  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 15, 2018Infusion or Flow Problem; Infusion or Flow Problem

    THE USER FACILITY REPORTED THAT THE DEVICE COLLECTED 500ML OF BLOOD AND COULD NOT BE RE-INFUSED BACK TO THE PATIENT DURING A PROCEDURE. THERE WAS NO DELAY, NO MEDICAL INTERVENTION, AND NO ADVERSE CONSEQUENCES.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 7784412 ↗

Other APPARATUS, AUTOTRANSFUSION devices

All APPARATUS, AUTOTRANSFUSION devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.