FDA Medical Device Recalls (openFDA)
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. The device is indicated for use in sealing the femoral arterial puncture site.
- Recall number
- Z-0762-04
- 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.
- Status
- Terminated
- Initiated
- 2003-07-28
- Posted
- 2004-07-20
- Terminated
- 2004-04-06
- Reason
- Kits are missing the temporary arteriotomy locator (TAL) from the blister package.
- Root cause
- Other
- Action
- 'Urgent Customer Advisory' Letter dated July 28, 2003.
- Quantity
- 1485 kits
- Distribution
- The device was distributed throughout the US to 101 direct accounts. There was one distributor. There was one government account.
- Lot, serial or model codes
- Lot No. 0605374, Exp. Date May 2005.
- 510(k) numbers
- not on file
- PMA numbers
- ["P920004"]
- Product code
- MGB
- Firm FEI
- 3003071194
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28