Reprocessed EP Catheter (2018-03-29) — recall 60916
Health Canada — Medical Devices · Canada · 2018-05-11 · Type II
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Reported risk: In support of international clearance activities for the CS Uni-Directional Diagnostic EP D135303 and D135304 Catheters, it was determined that the catheters should be used only in patients that have received anticoagulants prior to or during the procedure in order to mitigate risk of thrombosis formation. Updates were made to the IFU to provide clarity on the usage of anticoagulants with the CS Uni-Directional Diagnostic EP D135303 and D135304 Catheters.There have been no D135304 complaints or reports of adverse events received relating to thrombogenicity.
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