Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath (2018-03-05)

Starting date:

March 5, 2018

Posting date:

April 6, 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-66392

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  Reason
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  Affected products

Affected products

Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath

Reason

An inspection method issue may have affected the inner lumen of the guide sheaths (it is estimated that this can be found in approximately 2% of units). While no complaints or patient adverse events have been reported to the firm, it is possible that if used, this could lead to the embolization of guide sheath inner lumen material.

Affected products