Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter Recalled by Stryker Sustainability Solutions Due to Thrombogenicity test results demonstrated that both the test...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Sustainability Solutions directly.
Affected 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.
Quantity: 2,722 units
Why Was This Recalled?
Thrombogenicity test results demonstrated that both the test devices (SSS) and control devices (OM) did not meet the internal specification of non-thrombogenic .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Stryker Sustainability Solutions
Stryker Sustainability Solutions has 38 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report