Boston Scientific Corporation: WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered 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): M00516750

Recall number

Z-3280-2024

Recalling firm

Boston Scientific Corporation

Product

WALLFLEX ESOPHAGEAL FC 23/28MMX15CM-Wallflex Esophageal Partially Covered and Fully Covered 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): M00516750

Status

Open, Classified

Initiated

2024-08-01

Posted

2024-09-26

Terminated

not on file

Reason

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

Root 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

516 units

Distribution

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

Lot, serial or model codes

GTIN: 08714729778080 Lot Numbers: 32809369, 32809370, 32820234 ,32829719, 32837015, 32859849, 32888837, 32888838, 32914768, 32919658, 32919659, 32938991 32956256, 32977683, 32980850, 32986659, 32994875, 32998177, 33014830, 33101458, 33119730, 33176329, 33195046, 33195048 33208043, 33208044, 33218761, 33242625, 33266646, 33266649

510(k) numbers

["K233939"]

PMA numbers

not on file

Product code

ESW

Firm FEI

3005099803

Firm city

Marlborough

Firm state

MA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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