Recall Z-2426-2018— Stryker Sustainability Solutions

Name: FDA recall Z-2426-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-29

Class II · Terminated

Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2018-03-29, terminated 2020-07-28. It names one FDA 510(k) clearance: K100254. 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.. Reason: Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic ..

Recalling firm: Stryker Sustainability Solutions
Classification: Class II
Status: Terminated
Initiated: 2018-03-29
Terminated: 2020-07-28
Firm location: Tempe, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K100254 — REPROCESSED CS BI-DIECTIONAL DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERAscent Healthcare Solutions·cleared 2010-05-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.