Datascope Collagen Products Division VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. T Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in cardboard shelf cartons containing 5 ea. individual kits. The individual kits are packaged in a blister with Tyvek lid within a heat sealed foil pouch and fiberboard envelope. The device delivers collagen to the surface of the femoral artery following diagnostic or interventional catherization procedures using 5-8 Fr. procedural sheaths. T
Brand
Datascope Collagen Products Division
Lot Codes / Batch Numbers
Lot No. 0605374, Exp. Date May 2005.
Products Sold
Lot No. 0605374, Exp. Date May 2005.
Datascope Collagen Products Division is recalling VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920 due to Kits are missing the temporary arteriotomy locator (TAL) from the blister package.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Kits are missing the temporary arteriotomy locator (TAL) from the blister package.
Recommended Action
Per FDA guidance
'Urgent Customer Advisory' Letter dated July 28, 2003.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026