Z-0563-04

Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965

Name: Z-0563-04 Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
Creator: Boston Scientific Corporation
Published: 2004-01-28
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2004-01-28 / Terminated / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965 on 2004-01-28. The reason FDA records is "Incorrect label states stent covered with 'Permalume Covering', product is uncovered". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0563-04
Status: Terminated
Initiated: 2004-01-28
Posted: 2004-07-20
Terminated: 2006-06-28
Recalling firm: Boston Scientific Corporation
Product: Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
Reason for recall: Incorrect label states stent covered with 'Permalume Covering', product is uncovered
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
Quantity in commerce: 12 units
Distribution: CA, GA, , MD, NY, OR, ND, PA Netherlands
Product codes and lots: Lot Number: 6023979

Product code FGE

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)