AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile recall
AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
Why was AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile recalled?
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
GTIN: 00191506006662 Lot Numbers: 32889020, 33178844
- Product
- AGILE ESO FC RMV 23MM X 6.2CM IN 18.5 FR-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 7 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of APAC, Canada, EMEA, LATAM.
- Recall date
- October 2, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)