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.
FDA Recall Z-2426-2018 · Posted None
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Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeNLH
Date Initiated2018-03-29
Date Terminated2020-07-28
Product Quantity2,722 units
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 .
Firm Action
The recalling firm issued a notification letter to their sales representatives via email on 3/29/2018 with a response form. For customers who did not return the response form, their will be a subsequent email or fax to their sales rep. The company will continue to follow up via phone and email as needed. The letter identified the affected product, problem and actions to be taken.
Root Cause
Use error
Distribution Pattern
Worldwide Distribution - US Nationwide and Canada
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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