Z-3292-2024Class II

AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW...

Name: Z-3292-2024 AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW...
Creator: Boston Scientific Corporation
Published: 2024-08-01
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2024-08-01 / Open, Classified / root cause: manufacturing process

FDA source

Boston Scientific Corporation began a recall of AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal... on 2024-08-01. FDA classified it as Class II and gives the reason as "WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3292-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-08-01
Posted: 2024-09-26
Recalling firm: Boston Scientific Corporation
Product: AGILE ESO OTW FC 23MM X 15.0CM IN 18.5 F-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): M00517780
Product code: ESW Prosthesis, Esophageal
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.
Root cause tag: manufacturing process
FDA 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: [email protected] 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: 19 units
Distribution: Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
Product codes and lots: GTIN: 00191506006655 Lot Numbers: 33266651

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3292-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3265-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3266-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3267-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3268-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3269-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3270-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3271-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3272-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3273-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3274-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3275-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3276-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3277-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3278-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3279-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3280-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3281-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3282-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3283-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3284-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3285-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3286-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3287-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3288-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3289-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3290-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3291-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3292-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3293-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3294-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26
Z-3295-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26

Product code ESW

K233837Class IIAgile Esophageal Stent SystemBoston Scientific Corporation / cleared 2024-04-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)