RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
Recall
- Recall Number
- Z-0749-2010
- Event Number
- 53607
- Firm
- Abbott Vascular-Cardiac Therapies dba Guidant Corporation
- FEI Number
- 2024168
- Product Code
- NIM
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- October 1, 2009
- Posted
- January 29, 2010
- Terminated
- September 27, 2011
- Address
- 26531 Ynez Rd, Temecula, CA, 92591-4630
Description
RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization.
The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for catheter shaft tensile strength.
Abbott Vascular's Sales Representatives initiated customer contact with the identified consignees beginning October 1, 2009 . They provided the consignees with a recall letter with attached fax-back effectiveness check form. The recall letter instructed the consignees to work with their local account representative to review their inventory, complete the attached recall effectiveness check form and return identified products to Abbott Vascular. For further information, contact Abbott Vascular Customer Service at 1-800-227-9902.
Nationwide Distribution.
22 units