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ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVS) (2015-12-07)
- Starting date:
- December 7, 2015
- Posting date:
- December 24, 2015
- 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-56464
Recalled Products
A. ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVS)
Reason
Abbott Vascular has recently published the results of Absorb III, a clinical trial that compared the safety and effectiveness of Absorb BVS to the XIENCE, metallic drug eluting stent. Learnings from an analysis of the Absorb III data and other published data have identified an impact on clinical outcomes following changes to procedural techniques. Implementation of these techniques is expected to facilitate optimal clinical outcomes and reduce the possibility of thrombosis. Abbott Vascular will be updating the instructions for use (IFU) with this information.
Affected products
A. ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM (BVS)
Lot or serial number
All lots.
Model or catalog number
1012462-12
1012462-18
1012462-23
1012462-28
1012463-12
1012463-18
1012463-23
1012463-28
1012464-12
1012464-18
1012464-23
1012464-28
Companies
- Manufacturer
-
Abbott Vascular
3200 Lakeside Drive
Santa Clara
95054-2807
California
UNITED STATES