Class 2 Device Recall WALLFLEX FC ESO STENT

• Date Initiated by Firm: August 01, 2024
• Date Posted: September 26, 2024
• Recall Status: Open, Classified
• Recall Number: Z-3269-2024
• Recall Event ID: 95124
• 510(K)Number: K233939
• Product Classification: Prosthesis, esophageal - Product Code ESW
• Product: WALLFLEX FC ESO STENT RMV 23X125MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516250
• Code Information: GTIN: 08714729854517 Lot Numbers: 32809368, 32846904, 32856377, 32867089, 32898068, 32908416, 32914771, 32919348, 32938992, 33058575
• FEI Number: 3005099803
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 100 Boston Scientific Way; Marlborough MA 01752-1234
• For Additional Information Contact: Rebecca KinKead Rubio ; 651-581-0761
• Manufacturer Reason for Recall: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
• FDA Determined Cause: Process control
• Action: Boston Scientific issued Urgent Medical Device Removal - Immediate Action Required to US consignees WallFlexTM Esophageal Stent System AgileTM Esophageal Over the Wire (OTW) Stent System via Fedex Priority Overnight on August 1, 2024. Foreign consignees notified 8/1/24 via either Fedex DHL, Email. Letter states reason for recall, health risk and action to take: This removal affects only the products, and lots listed in Attachment 1 (Affected Products). Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device. Share this notice with any health care professional within your organization and with any organization where the affected devices may have been transferred. If you are a distributor, this notification must be forwarded to your customers to ensure notification of this product removal is carried out to the end-user level. If you are a facility that has sent products to another hospital or a facility within your network, ensure this notification is forwarded to them. The Reply Verification Tracking Form (RVTF) enclosed with this Removal Notice must be completed and returned even if you do not have any affected products. Reach out to your local Boston Scientific representative with any questions. 1. Immediately discontinue use and segregate affected product. 2. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. " Indicate the quantity of SINGLE units you will be returning for credit " If you have product that is listed in Attachment 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF " Return the RVTF via: Email: BSCFieldActionCenter@bsci.com or Fax: BSC Field Action Center 1-763-415-7708 3. Once Boston Scientific receives your completed RVTF, you will be contacted in approximately 2 business days and provided an RGA number for prod
• Quantity in Commerce: 176 units
• Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
• 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = ESW