Health product recall

Edwards PASCAL Transcatheter Valve Repair System (2019-04-28)

Starting date:
April 28, 2019
Posting date:
May 24, 2019
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-70013

Last updated: 2019-05-24

Affected Products

Edwards PASCAL Transcatheter Valve Repair System

Reason

A potential procedural factor has been identified by Edwards, which may occur during the use of the pascal transcatheter valve repair system.  In a limited number of cases, observations of air bubbles have been made following insertion of the Implant System into the Guide Sheath.  Although air bubbles are commonly observed during use of transcatheter devices, in at least one case it is believed that the introduction of air resulted in a coronary air embolism, which required medical intervention to stabilize the patient before successfully completing the PASCAL procedure.  Edwards is taking this opportunity to update the physician training materials to add clarity around the minimum volume of aspiration required and specifics for de-airing tools and techniques.

Affected products

Edwards PASCAL Transcatheter Valve Repair System

Lot or serial number

All lots.

Model or catalog number

10000GSCL
10000GSCLUS
10000GSCUST
10000ISCL
10000ISCLUS
10000ISCUST
10000ISM
10000ISMCL

Companies
Manufacturer
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES