Z-0762-04

VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004)...

Name: Z-0762-04 VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004)...
Creator: Datascope Collagen Products Division
Published: 2003-07-28
License: https://open.fda.gov/license/

Datascope Collagen Products Division / initiated 2003-07-28 / Terminated / root cause: packaging

FDA source

Datascope Collagen Products Division began a recall of VasoSeal ES, Extravascular Security Vascular Closure Device, Catalog No. 76000. Class III (PMA P920004), sterile (via gamma irradiation) device is sold in... on 2003-07-28. The reason FDA records is "Kits are missing the temporary arteriotomy locator (TAL) from the blister package". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0762-04
Status: Terminated
Initiated: 2003-07-28
Posted: 2004-07-20
Terminated: 2004-04-06
Recalling firm: Datascope Collagen Products Division
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. The device is indicated for use in sealing the femoral arterial puncture site.
Product code: MGB Device, Hemostasis, Vascular
Reason for recall: Kits are missing the temporary arteriotomy locator (TAL) from the blister package.
Root cause tag: packaging
FDA root cause: Other
Action: 'Urgent Customer Advisory' Letter dated July 28, 2003.
Quantity in commerce: 1485 kits
Distribution: The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.
Product codes and lots: Lot No. 0605374, Exp. Date May 2005.

Product code MGB

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)