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U.S. Department of Health and Human Services

Class 2 Device Recall WallFlexTM Biliary RX Fully Covered Stent System RMV

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  Class 2 Device Recall WallFlexTM Biliary RX Fully Covered Stent System RMV see related information
Date Initiated by Firm August 07, 2020
Create Date September 12, 2020
Recall Status1 Terminated 3 on December 23, 2020
Recall Number Z-2958-2020
Recall Event ID 86226
510(K)Number K140630  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
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.
Code Information Lot code:25607019 Exp. Date: June 17th , 2022  GIN:08714729953180  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
For Additional Information Contact Nicole Pshon
763-494-1556
Manufacturer Reason
for Recall		 Mislabeled: WallFlex Biliary RX Uncovered Stent System 10x60mm devices labeled as WallFlexTM Biliary RX Fully Covered Stent System RMV 10x60mm device
FDA Determined
Cause 2		 Packaging process control
Action 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.
Quantity in Commerce 40 units
Distribution US Nationwide distribution.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = BOSTON SCIENTIFIC
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