Events

Recall of Hemashield Vantage Vascular Graft. Vascular graft prosthesis.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Boston Scientific Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    32513
  • Event Risk Class
    Class 1
  • Event Number
    Z-1459-05
  • Event Initiated Date
    2005-06-27
  • Event Date Posted
    2005-09-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40222
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Prosthesis, Vascular Graft, Of 6mm And Greater Diameter - Product Code DSY
  • Reason
    During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
  • 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.

Device

Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
  • Model / Serial
    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.
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • 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 Description
    Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Manufacturer Address
    Boston Scientific Corporation, 1 Boston Scientific Pl, Natick MA 01760-1536
  • Source
    USFDA