Hemashield Vantage Vascular Graft. Vascular graft prosthesis.
FDA Recall Z-1459-05 · Posted 2005-09-28
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Recalling FirmBoston Scientific Corporation
Recall StatusTerminated
Product CodeDSY
Date Initiated2005-06-27
Date Terminated2006-08-21
Product Quantity3487 devices
Reason for Recall
During surgery, several reports of the grafts fraying and tearing upon suturing by the surgeon.
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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