WallFlex Biliary recallZ-2958-2020 · Boston Scientific Corporation · initiated Aug 7, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
FDA root cause category: Packaging process control
What the company is doing
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: [email protected] 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.
Recall details
- Recall number
- Z-2958-2020
- Status
- Terminated
- Initiated by the company
- Aug 7, 2020
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 40 units
- Product code
- FGE
- FDA submissions
- K140630
- Distribution
- US Nationwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
Lot code:25607019 Exp. Date: June 17th , 2022 GIN:08714729953180
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- WallFlex Biliary M00570370Boston Scientific Corporation · Biliary stent system for benign strictures1 recall3 deaths166 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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