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U.S. Department of Health and Human Services

Class 2 Device Recall The Greenfield Vena Cava Filter

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  Class 2 Device Recall The Greenfield Vena Cava Filter see related information
Date Initiated by Firm August 05, 2005
Date Posted December 23, 2005
Recall Status1 Terminated 3 on November 09, 2006
Recall Number Z-0300-06
Recall Event ID 32889
510(K)Number K901659  
Product Classification Filter, Intravascular, Cardiovascular - Product Code DTK
Product Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd., Cork, Ireland. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. The devices are permanently implanted devices designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. It is inserted through the internal jugular or femoral vein using a percutaneous puncture or surgical cutdown. The Titanium Greeenfield Vena Cava Filter comes preloaded in a jugular or a femoral introducer catheter.
Code Information Lot numbers: 7129578 and 7124116
Recalling Firm/
Boston Scientific Scimed
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall
Certain units within eleven lots of the 12 Fr Greenfield Vena Cava Filter may lack a taper on the braided sheath of the delivery system. The lack of a taper could lead to vessel damage as a result of the sheath catching on the edge of the vein and causing a tear.
FDA Determined
Cause 2
Action Urgent Recall Notice dated 08/04/05 was Federal Express''d to customers for delivery on 08/05/05. This notice informs customers of the issue and identifies affected product. Customers are asked to immediately discontinue use of and segregate these recalled lots. Steps for Voluntary Recall and Tracking/Verification Form were sent to the Risk Manager only. The Tracking/Verification Form is to be completed by the Risk Manager even if there are no affected lots to return. To return affected product, the customer must call Boston Scientific Corporation (BSC) to obtain a Returned Goods Authorization (RGA) number. Returned Goods are to be packaged and sent to BSC with the Tracking/Verification Form and using the enclosed red/white field action return shipping label to: Boston Scientific Marina Bay, 500 Commander Shea Blvd., Quincy, MA 02171
Distribution OUS includes countries of Chile, Japan, Netherlands and Taiwan. Within the US to: AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NY, OH, OR, PA, SC, TN, TX, VA and WI
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.
510(K) Database 510(K)s with Product Code = DTK and Original Applicant = BOSTON SCIENTIFIC CORP.