Recall Z-3295-2024 ยท ESW Prosthesis, Esophageal
Boston Scientific Corporation
AGILE ESO FC RMV 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): M00517820
| Date | Sep 26, 2024 (initiated Aug 1, 2024) |
| Status | Open, Classified |
| 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 hand |
| Quantity | 6 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K233837 | Agile Esophageal Stent System Boston Scientific Corporation, Apr 4, 2024 |