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

Recalled July 18, 2018 · FDA recall Z-2426-2018 · Stryker Sustainability Solutions

Hazard

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

Units

2,722 units

Sold at

Worldwide Distribution - US Nationwide and Canada

Description

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

Product

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.

Manufacturer(s)

Stryker Sustainability Solutions

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →