Boston Scientific Corporation WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usage: is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms and relief of malignant biliary obstruction prior to surgery.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
Lot code:25607019 Exp. Date: June 17th, 2022 GIN:08714729953180
Products Sold
Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180
Boston Scientific Corporation is recalling WallFlexTM Biliary RX Fully Covered Stent System RMV (10mmx60mm Stent) UPN: M00570370 - Product Usag due to Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
Recommended Action
Per FDA guidance
Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required on July 31, 2020, via BSC Sales Representatives. The Sales Representatives contacted accounts to determine whether or not the affected inventory had been used. If the product was not used at the site, the product was quarantined. Additionally, customer notification letters to the 32 consignees were sent via Federal Express Priority Overnight mail on July 31st, 2020. Letter states reason for recall, health risk and action to take: Your local Boston Scientific sales representative is available to support this removal. 1. Immediately segregate the affected product to ensure that it will not be used. 2. Contact the Boston Scientific Field Action center for an RGA number to facilitate product return. 3. Ship product back to Boston Scientific We recommend clinical re-evaluation of patients implanted with an uncovered stent from this lot to determine if stent removal is appropriate. 1. Immediately discontinue use of and segregate affected product. 2. Complete the enclosed Reply Verification Tracking Form. 3. Indicate on your Verification Form the quantity of units that you will be returning. 4. Email or fax the Reply Verification Tracking Form to the BSC Field Action Center as described Email: BSCFieldActionCenter@bsci.com or Fax to: Field Action Center 1-866-213-1806. Please email or fax your Reply Verification Tracking Form(s) immediately. Replacement devices will be issued for all product returning to Boston Scientific.
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