Stryker Sustainability Solutions recalls Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Pr…

Recall date

March 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2426-2018

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

Worldwide Distribution - US Nationwide and Canada

Why it was recalled

Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.