Reprocessed EP Catheter (2018-03-29)

Starting date:

March 29, 2018

Posting date:

May 11, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-66724

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  Reason
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  Affected products

Affected products

Reprocessed EP Catheter

Reason

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.

Affected products