FDA-Device2018-07-18Class II
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.
Hazard
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
Sold states
Worldwide Distribution - US Nationwide and Canada
Affected count
2,722 units
Manufactured in
1810 W Drake Dr, Tempe, AZ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2426-2018More Stryker Sustainability Solutions recalls
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