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
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
Edwards PASCAL Transcatheter Valve Repair System
Lot or serial number
Not applicable.
Model or catalog number
10000IS
10000ISM
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
California
UNITED STATES