WALLFLEX FC ESO STENT RMV LL 23X105- Intended for recall
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic…
Why was WALLFLEX FC ESO STENT RMV LL 23X105- Intended for 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: 08714729905554 Lot Numbers: 32771052, 32846905
- Product
- WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 40 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)