Abbott Vascular-Cardiac Therapies dba Guidant Corporation 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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Lot Codes / Batch Numbers
Lot Number: 9081851
Products Sold
Lot Number: 9081851
Abbott Vascular-Cardiac Therapies dba Guidant Corporation is recalling RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40, Lot Number: 9081851. Indica due to The recall was initiated after Abbott Vascular discovered, through internal testing, that the affected lot may not meet our quality specifications for. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026