510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
Z-1459-05

Hemashield Vantage Vascular Graft. Vascular graft prosthesis

Boston Scientific Corporation / initiated 2005-06-27 / Terminated
FDA source (opens on fda.gov)

Boston Scientific Corporation began a recall of Hemashield Vantage Vascular Graft. Vascular graft prosthesis on . The reason FDA records is "During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1459-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Boston Scientific Corporation
Product
Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
Product code
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall
During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
FDA root cause
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.
Product codes and lots
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.