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U.S. Department of Health and Human Services

Class 1 Device Recall Greenfield Vena Cava Filter System

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  Class 1 Device Recall Greenfield Vena Cava Filter System see related information
Date Initiated by Firm December 02, 2005
Date Posted December 20, 2005
Recall Status1 Terminated 3 on April 02, 2007
Recall Number Z-0280-06
Recall Event ID 34134
510(K)Number K964284  
Product Classification Filter, Intravascular, Cardiovascular - Product Code DTK
Product Stainless Steel Greenfield Vena Cava Filter with 12 Fr / 4,0 mm FlexCarrier Capsule. For Femoral Vein Introduction Only. Order No. 50-501. Sterile EO. Single Use Only. Read Instructions for Use before using this device. Distributed in USA by: Boston Scientific Corporation, One Boston Scientific Place, Natick, MA USA 01760. Manufacturer: Boston Scientific Cork Ltd., Business & Technology Park, Model Farm Road, Cork, Ireland. The Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm introducer System is a permanently implanted stainless steel device designed to protect against pulmonary embolism while maintaining patency of the inferior vena cava. The Stainless Steel Greenfield Vena Cava Filter comes preloaded in a 12 Fr. / 4,0 mm jugular or femoral introducer catheter.
Code Information all codes of product manufactured before March 10, 2004. Catalog no. 50-501 with lot/batch # between 5145758 and 6387904
Recalling Firm/
Manufacturer		 Boston Scientific
1 Scimed Pl
Maple Grove MN 55311-1565
Manufacturer Reason
for Recall		 There have been reports of detachment at the bond between the carrier capsule and the outer sheath of the Greenfield Vena Cava Filters with 12 Fr Femoral introducer Systems manufactured before Marcyh 10, 2004. If the capsule should detach during an implantation procedure, there is a risk of cardiac and pulmonary embolization.
FDA Determined
Cause 2		 Other
Action Recall packages started going out 12/02/05 via Fed Ex and was completed 12/03/05. A letter was directed to several persons within each hospital . The letter describes the issues, the affected lot numbers and the complaints that Boston Scientific has received. Affected devices are to be segregated for return back to Boston Scientific. A 'Reply Verification Tracking Form' is asked to be returned back to Boston Scientific.
Quantity in Commerce 18,000
Distribution nationwide (except ND); Virgin Islands, OUS to include: united Arab Emirates, Argentina, Australia, Belgium, Brunei Darussalam, Brazil, Canada, Chile, China, Colombia, Germany, Spain, France, Ireland, Great Britain, Israel, India, Italy, Jamaica, Jordan, Japan, Korea (South Republic), Kuwait, Lebanon, Mexico, Malaysia, Netherlands, New Zealand, Panama, Philippines, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Thailand, Trinidad and Tobago, Taiwan, Venezuela
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.
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