—#209738

Product

AGILE ESO OTW PC 23MM X 6.2CM IN 18.5 FR- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is 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): M00517710

FDA product code: ESW — Prosthesis, Esophageal
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K233837
Affected lot / code info: GTIN: 00191506006587 Lot Numbers: 33178843

Why it was recalled

WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

Root cause (FDA determination)

Process control

Action the firm took

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

Recalling firm

Firm: Boston Scientific Corporation
Address: 100 Boston Scientific Way, Marlborough, Massachusetts 01752-1234

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.

Timeline

Recall initiated: 2024-08-01
Posted by FDA: 2024-09-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #209738. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.