Boston Scientific Corporation Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Number: 6965
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot Number: 6023979
Products Sold
Lot Number: 6023979
Boston Scientific Corporation is recalling Wallstent Rx Biliary Endoprosthesis with Unistep Plus Delivery System 8 Fr, 10mm x 60mm Catalog Nu due to Incorrect label states stent covered with 'Permalume Covering', product is uncovered. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Incorrect label states stent covered with 'Permalume Covering', product is uncovered
Recommended Action
Per FDA guidance
Boston Scientific notified domestic and international accounts by letter on 1/28/04. Accounts are requested to return product.
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 noticeDistribution
As reported by FDA
CA, GA, MD, NY, ND, OR, PA
Page updated: Jan 10, 2026