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U.S. Department of Health and Human Services

Class 1 Device Recall

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  Class 1 Device Recall see related information
Date Initiated by Firm June 27, 2005
Date Posted September 28, 2005
Recall Status1 Terminated 3 on August 21, 2006
Recall Number Z-1459-05
Recall Event ID 32513
510(K)Number K961847  
Product Classification Prosthesis, Vascular Graft, Of 6mm And Greater Diameter - Product Code DSY
Product Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
Code Information Catalog Number, Product Description, Lot Number:  M002023750060, HVVG 6mm x 100cm, 5649003; M002023750060, HVVG 6mm x 100cm, 5948031; M002023750060, HVVG 6mm x 100cm, 6639821; M002023750060, HVVG 6mm x 100cm, 6647296; M002023750060, HVVG 6mm x 100cm, 7030066; M002023750070, HVVG 7mm x 100cm, 5669601; M002023750070, HVVG 7mm x 100cm, 5728283; M002023750070, HVVG 7mm x 100cm, 5821740; M002023750070, HVVG 7mm x 100cm, 6032950; M002023750070, HVVG 7mm x 100cm, 6962284; M002023750080, HVVG 8mm x 100cm, 6007978; M002023750080, HVVG 8mm x 100cm, 6279546; M002023750080, HVVG 8mm x 100cm,6722180; M002023750080, HVVG 8mm x 100cm, 6919131; M002023750080, HVVG 8mm x 100cm, 7161034; M002023750080, HVVG 8mm x 100cm, 7249926; M002023750080, HVVG 8mm x 100cm, 7402224; M002023750100, HVVG 10mm x 100cm, 6876321; M002023750100, HVVG 10mm x 100cm, 6962286; M002023754060, HVVG 6mm x 40cm, 5721446; M002023754060, HVVG 6mm x 40cm, 5728284; M002023754060, HVVG 6mm x 40cm, 5780318; M002023754060, HVVG 6mm x 40cm, 5860237; M002023754060, HVVG 6mm x 40cm, 5899944; M002023754060, HVVG 6mm x 40cm, 6011811; M002023754060, HVVG 6mm x 40cm, 6239445; M002023754060, HVVG 6mm x 40cm, 6268215; M002023754060, HVVG 6mm x 40cm, 6304504; M002023754060, HVVG 6mm x 40cm, 6320785; M002023754060, HVVG 6mm x 40cm, 6364795; M002023754060, HVVG 6mm x 40cm, 6440114; M002023754060, HVVG 6mm x 40cm, 6615660; M002023754060, HVVG 6mm x 40cm, 6628696; M002023754060, HVVG 6mm x 40cm, 6647104; M002023754060, HVVG 6mm x 40cm, 6696492; M002023754060, HVVG 6mm x 40cm, 6807737; M002023754060, HVVG 6mm x 40cm, 6917823; M002023754060, HVVG 6mm x 40cm, 6979854; M002023754060, HVVG 6mm x 40cm, 7000352; M002023754060, HVVG 6mm x 40cm, 7071546; M002023754060, HVVG 6mm x 40cm, 7200982; M002023754070, HVVG 7mm x 40cm, 5691792; M002023754070, HVVG 7mm x 40cm, 5726049; M002023754070, HVVG 7mm x 40cm, 5779847; M002023754070, HVVG 7mm x 40cm, 5797094; M002023754070, HVVG 7mm x 40cm, 5955887; M002023754070, HVVG 7mm x 40cm, 6011812; M002023754070, HVVG 7mm x 40cm, 6037086; M002023754070, HVVG 7mm x 40cm, 6136721; M002023754070, HVVG 7mm x 40cm, 6611338; M002023754070, HVVG 7mm x 40cm, 6657664; M002023754070, HVVG 7mm x 40cm, 6691603; M002023754070, HVVG 7mm x 40cm, 6851214; M002023754070, HVVG 7mm x 40cm, 7161578; M002023754070, HVVG 7mm x 40cm, 7175592; M002023754070, HVVG 7mm x 40cm, 7249015; M002023754070, HVVG 7mm x 40cm, 7402368; M002023754070, HVVG 7mm x 40cm, 7403197; M002023754070, HVVG 7mm x 40cm, 7535410; M002023754070, HVVG 7mm x 40cm, 7565108; M002023754070, HVVG 7mm x 40cm, 7631134; M002023754080, HVVG 8mm x 40cm, 5669605; M002023754080, HVVG 8mm x 40cm, 5728288; M002023754080, HVVG 8mm x 40cm, 5783271; M002023754080, HVVG 8mm x 40cm, 5797165; M002023754080, HVVG 8mm x 40cm, 5841181; M002023754080, HVVG 8mm x 40cm, 5912738; M002023754080, HVVG 8mm x 40cm, 5976346; M002023754080, HVVG 8mm x 40cm, 6008050; M002023754080, HVVG 8mm x 40cm, 6107641; M002023754080, HVVG 8mm x 40cm, 6138907; M002023754080, HVVG 8mm x 40cm, 6238549; M002023754080, HVVG 8mm x 40cm, 6320790; M002023754080, HVVG 8mm x 40cm, 6361655; M002023754080, HVVG 8mm x 40cm, 6427209; M002023754080, HVVG 8mm x 40cm, 6598660; M002023754080, HVVG 8mm x 40cm, 6617325; M002023754080, HVVG 8mm x 40cm, 6646329; M002023754080, HVVG 8mm x 40cm, 6647152; M002023754080, HVVG 8mm x 40cm, 6691608; M002023754080, HVVG 8mm x 40cm, 6876382; M002023754080, HVVG 8mm x 40cm, 7114368; M002023754080, HVVG 8mm x 40cm, 7138064; M002023754080, HVVG 8mm x 40cm, 7161580; M002023754080, HVVG 8mm x 40cm, 7175587; M002023754080, HVVG 8mm x 40cm, 7276583; M002023754080, HVVG 8mm x 40cm, 7402360; M002023754080, HVVG 8mm x 40cm, 7535409; M002023754100, HVVG 10mm x 40cm, 5691791; M002023754100, HVVG 10mm x 40cm, 5731519; M002023754100, HVVG 10mm x 40cm, 5891897; M002023754100, HVVG 10mm x 40cm, 6052007; M002023754100, HVVG 10mm x 40cm, 6418381; M002023754100, HVVG 10mm x 40cm, 6926326; M002023754100, HVVG 10mm x 40cm, 7000766; M002023754100, HVVG 10mm x 40cm, 7504489; M002023756060, HVVG 6mm x 60cm, 5707200; M002023756060, HVVG 6mm x 60cm, 5724793; M002023756060, HVVG 6mm x 60cm, 5745982; M002023756060, HVVG 6mm x 60cm, 5767491; M002023756060, HVVG 6mm x 60cm, 5767495; M002023756060, HVVG 6mm x 60cm, 5852837; M002023756060, HVVG 6mm x 60cm, 5853224; M002023756060, HVVG 6mm x 60cm, 5891798; M002023756060, HVVG 6mm x 60cm, 5947960; M002023756060, HVVG 6mm x 60cm, 5968420; M002023756060, HVVG 6mm x 60cm, 5988577; M002023756060, HVVG 6mm x 60cm, 6050593; M002023756060, HVVG 6mm x 60cm, 6096033; M002023756060, HVVG 6mm x 60cm, 6268220; M002023756060, HVVG 6mm x 60cm, 6347541; M002023756060, HVVG 6mm x 60cm, 6388858; M002023756060, HVVG 6mm x 60cm, 6418565; M002023756060, HVVG 6mm x 60cm, 6611350; M002023756060, HVVG 6mm x 60cm, 6628703; M002023756060, HVVG 6mm x 60cm, 6654862; M002023756060, HVVG 6mm x 60cm, 6655453; M002023756060, HVVG 6mm x 60cm, 6770384; M002023756060, HVVG 6mm x 60cm, 6807126; M002023756060, HVVG 6mm x 60cm, 6850094; M002023756060, HVVG 6mm x 60cm, 6919450; M002023756060, HVVG 6mm x 60cm, 7010071; M002023756060, HVVG 6mm x 60cm, 7057154; M002023756060, HVVG 6mm x 60cm, 7075488; M002023756060, HVVG 6mm x 60cm, 7161035; M002023756060, HVVG 6mm x 60cm, 7173034; M002023756060, HVVG 6mm x 60cm, 7230491; M002023756060, HVVG 6mm x 60cm, 7259726; M002023756060, HVVG 6mm x 60cm, 7528090; M002023756070, HVVG 7mm x 60cm, 5633991; M002023756070, HVVG 7mm x 60cm, 5691790; M002023756070, HVVG 7mm x 60cm, 5745981; M002023756070, HVVG 7mm x 60cm, 5773786; M002023756070, HVVG 7mm x 60cm, 5793283; M002023756070, HVVG 7mm x 60cm, 5853511; M002023756070, HVVG 7mm x 60cm, 5903684; M002023756070, HVVG 7mm x 60cm, 5988575; M002023756070, HVVG 7mm x 60cm, 6011813; M002023756070, HVVG 7mm x 60cm, 6037090; M002023756070, HVVG 7mm x 60cm, 6109301; M002023756070, HVVG 7mm x 60cm, 6282450; M002023756070, HVVG 7mm x 60cm, 6383841; M002023756070, HVVG 7mm x 60cm, 6440361; M002023756070, HVVG 7mm x 60cm, 6611337; M002023756070, HVVG 7mm x 60cm, 6667242; M002023756070, HVVG 7mm x 60cm, 6754019; M002023756070, HVVG 7mm x 60cm, 6930145; M002023756070, HVVG 7mm x 60cm, 7137399; M002023756070, HVVG 7mm x 60cm, 7276579; M002023756070, HVVG 7mm x 60cm, 7403200; M002023756070, HVVG 7mm x 60cm, 7545048; M002023756070, HVVG 7mm x 60cm, 7545052; M002023756070, HVVG 7mm x 60cm, 7579389; M002023756080, HVVG 8mm x 60cm, 5633990; M002023756080, HVVG 8mm x 60cm, 5726141; M002023756080, HVVG 8mm x 60cm, 5856535; M002023756080, HVVG 8mm x 60cm, 5891889; M002023756080, HVVG 8mm x 60cm, 5948034; M002023756080, HVVG 8mm x 60cm, 6073565; M002023756080, HVVG 8mm x 60cm, 6185146; M002023756080, HVVG 8mm x 60cm, 6339117; M002023756080, HVVG 8mm x 60cm, 6388288; M002023756080, HVVG 8mm x 60cm, 6415673; M002023756080, HVVG 8mm x 60cm, 6598671; M002023756080, HVVG 8mm x 60cm, 6610550; M002023756080, HVVG 8mm x 60cm, 6628701; M002023756080, HVVG 8mm x 60cm, 6722144; M002023756080, HVVG 8mm x 60cm, 6754031; M002023756080, HVVG 8mm x 60cm, 6820115; M002023756080, HVVG 8mm x 60cm, 6861408; M002023756080, HVVG 8mm x 60cm, 6926327; M002023756080, HVVG 8mm x 60cm, 6948142; M002023756080, HVVG 8mm x 60cm, 7008949; M002023756080, HVVG 8mm x 60cm, 7071547; M002023756080, HVVG 8mm x 60cm, 7115438; M002023756080, HVVG 8mm x 60cm, 7528226; M002023756100, HVVG 10mm x 60cm, 5856641; M002023756100, HVVG 10mm x 60cm, 6051871; M002023756100, HVVG 10mm x 60cm, 6193600; M002023756100, HVVG 10mm x 60cm, 6524295; M002023756100, HVVG 10mm x 60cm, 6620113; M002023756100, HVVG 10mm x 60cm, 6691596; M002023756100, HVVG 10mm x 60cm, 6960306; M002023756100, HVVG 10mm x 60cm, 6961911; M002023758060, HVVG 6mm x 80cm, 5669380; M002023758060, HVVG 6mm x 80cm, 5779844; M002023758060, HVVG 6mm x 80cm, 5922480; M002023758060, HVVG 6mm x 80cm, 5964495; M002023758060, HVVG 6mm x 80cm, 6032948; M002023758060, HVVG 6mm x 80cm, 6216685; M002023758060, HVVG 6mm x 80cm, 6304505; M002023758060, HVVG 6mm x 80cm, 6347707; M002023758060, HVVG 6mm x 80cm, 6364796; M002023758060, HVVG 6mm x 80cm, 6388362; M002023758060, HVVG 6mm x 80cm, 6416301; M002023758060, HVVG 6mm x 80cm, 6615663; M002023758060, HVVG 6mm x 80cm, 6628554; M002023758060, HVVG 6mm x 80cm, 6646521; M002023758060, HVVG 6mm x 80cm, 6654376; M002023758060, HVVG 6mm x 80cm, 6696487; M002023758060, HVVG 6mm x 80cm, 6722189; M002023758060, HVVG 6mm x 80cm, 6774183; M002023758060, HVVG 6mm x 80cm, 6816154; M002023758060, HVVG 6mm x 80cm, 6930142; M002023758060, HVVG 6mm x 80cm, 7000351; M002023758060, HVVG 6mm x 80cm, 7010061; M002023758060, HVVG 6mm x 80cm, 7161036; M002023758060, HVVG 6mm x 80cm, 7230490; M002023758060, HVVG 6mm x 80cm, 7630848; M002023758070, HVVG 7mm x 80cm, 5724827; M002023758070, HVVG 7mm x 80cm, 5728287; M002023758070, HVVG 7mm x 80cm, 5955888; M002023758070, HVVG 7mm x 80cm, 6050597; M002023758070, HVVG 7mm x 80cm, 6230257; M002023758070, HVVG 7mm x 80cm, 6288273; M002023758070, HVVG 7mm x 80cm, 6440359; M002023758070, HVVG 7mm x 80cm, 6691602; M002023758070, HVVG 7mm x 80cm, 6770192; M002023758070, HVVG 7mm x 80cm, 6851207; M002023758070, HVVG 7mm x 80cm, 7161577; M002023758070, HVVG 7mm x 80cm, 7175590; M002023758070, HVVG 7mm x 80cm, 7248691; M002023758070, HVVG 7mm x 80cm, 7402229; M002023758070, HVVG 7mm x 80cm, 7402371; M002023758070, HVVG 7mm x 80cm, 7631133; M002023758080, HVVG 8mm x 80cm, 5700634; M002023758080, HVVG 8mm x 80cm, 5765239; M002023758080, HVVG 8mm x 80cm, 5815016; M002023758080, HVVG 8mm x 80cm, 5911567; M002023758080, HVVG 8mm x 80cm, 5972377; M002023758080, HVVG 8mm x 80cm, 6068815; M002023758080, HVVG 8mm x 80cm, 6238548; M002023758080, HVVG 8mm x 80cm, 6256385; M002023758080, HVVG 8mm x 80cm, 6320652; M002023758080, HVVG 8mm x 80cm, 6347706; M002023758080, HVVG 8mm x 80cm, 6416627; M002023758080, HVVG 8mm x 80cm, 6598409; M002023758080, HVVG 8mm x 80cm, 6617271; M002023758080, HVVG 8mm x 80cm, 6647222; M002023758080, HVVG 8mm x 80cm, 6691605; M002023758080, HVVG 8mm x 80cm, 6876377; M002023758080, HVVG 8mm x 80cm, 6962282; M002023758080, HVVG 8mm x 80cm, 7114366; M002023758080, HVVG 8mm x 80cm, 7138066; M002023758080, HVVG 8mm x 80cm, 7161579; M002023758080, HVVG 8mm x 80cm, 7220186; M002023758080, HVVG 8mm x 80cm, 7276584; M002023758080, HVVG 8mm x 80cm, 7317245; M002023758080, HVVG 8mm x 80cm, 7402219; M002023758100, HVVG 10mm x 80cm, 5783268; M002023758100, HVVG 10mm x 80cm, 5891786; M002023758100, HVVG 10mm x 80cm, 6165924; M002023758100, HVVG 10mm x 80cm, 6524301; M002023758100, HVVG 10mm x 80cm, 6598574; M002023758100, HVVG 10mm x 80cm, 7031876; M002023758100, HVVG 10mm x 80cm, 7317854; M002023758100, HVVG 10mm x 80cm, 7504480.    
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
1 Boston Scientific Pl
Natick MA 01760-1536
For Additional Information Contact Jennifer Bolton
763-494-1163
Manufacturer Reason
for Recall		 During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
FDA Determined
Cause 2		 Other
Action Recall notifications were sent out to all customers on 6/27/2005. Enclosed within the recall notification letters are Dear Doctor Letters with directions to the customers to supplyh a copy of it to each physician who has implanted the Hemashield Vantage Vascular Graft.
Quantity in Commerce 3487 devices
Distribution The devices were distributed to 375 customers in the US, Argentina, Australia, Belgium, China, Colombia, Czech Republic, Germany, Denmark, Spain, France, Great Britain, Italy, Kuwait, Lebanon, Mexico, Malaysia, Netherlands, Norway, New Zealand, Poland, Portugal, Sweden, Singapore and Taiwan.
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 = DSY and Original Applicant = MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP.
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