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U.S. Department of Health and Human Services

Class 2 Device Recall RX ACCULINK Carotid Stent System

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  Class 2 Device Recall RX ACCULINK Carotid Stent System see related information
Date Initiated by Firm October 01, 2009
Date Posted January 29, 2010
Recall Status1 Terminated 3 on September 27, 2011
Recall Number Z-0749-2010
Recall Event ID 53607
PMA Number P040012 
Product Classification Carotid Stent System - Product Code NIM
Product 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.
Code Information Lot Number: 9081851
Recalling Firm/
Manufacturer		 Abbott Vascular-Cardiac Therapies dba Guidant Corporation
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information Contact Deborah Rendahl
951-914-3535
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Process control
Action 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.
Quantity in Commerce 22 units
Distribution Nationwide Distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
PMA Database PMAs with Product Code = NIM and Original Applicant = ABBOTT VASCULAR
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