Edwards PASCAL Transcatheter Valve Repair System (2019-06-04)

Starting date:

June 4, 2019

Posting date:

June 28, 2019

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type III

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-70309

Last updated: 2019-06-28

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  Reason
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  Affected products

Affected Products

Edwards PASCAL Transcatheter Valve Repair System

Reason

Outside of Canada, Edwards Lifesciences has received limited reports, indicating the potential for a missing component (clasp positioning tool). The clasp positioning tool is attached to the implant system during the packaging operation in manufacturing. There is no affected product in Canada currently in distribution and there is no product retrieval necessary. Consistent with standard practices, all prior customers of this device are instructed to continue their proactive steps to visually inspect all devices prior to use.

Affected products