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
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
Edwards PASCAL Transcatheter Mitral Valve Repair System - Guide Sheath
Lot or serial number
61130785
Model or catalog number
10000GS
Companies
- Manufacturer
-
Edwards Lifesciences LLC
1 Edwards Way
Irvine
92614
UNITED STATES