Abbott Vascular-Cardiac Therapies dba Guidant Corporation Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral artery access sites after cardiovascular catheterization.
Brand
Abbott Vascular-Cardiac Therapies dba Guidant Corporation
Lot Codes / Batch Numbers
Lot Number 750406H
Products Sold
Lot Number 750406H
Abbott Vascular-Cardiac Therapies dba Guidant Corporation is recalling Abbott Vascular, StarClose Vascular Closure System Part Number 14677-01, for closure of femoral arte due to Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedur. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential sterility issue. Internal component quarantined for possible contamination, was released for sale after going through sterilization procedure.
Recommended Action
Per FDA guidance
Between May 6 and May 8, 2009, Sales Representatives visited accounts to recover the product. Recall notifications (Urgent Product Recall letters, dated May 6, 2009) were hand delivered to customers advising them Abbott Vascular is voluntarily recalling one lot of the StarClose Vascular Closure System for a potential stenlity issue discovered internally. Customers are asked to cease use of devices from this lot and work with their local account representative to review their inventory. complete the attached Recall Effectiveness Check Form and rerturn Identified products to Abbott Vascular.
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