Reported Oct 2, 2024 · Ongoing
WALLFLEX PC ESOPH STENT 23/28MM X 125MM- Wallflex Esophageal Partially Covered and Fully Covered Stent System is…
Boston Scientific Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Boston Scientific Corporation · 100 Boston Scientific Way · Marlborough, MA · 01752-1234
Is this the product you have?
- WALLFLEX PC ESOPH STENT 23/28MM X 125MM- 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)M00516940
- Lot codes and dates
- GTIN08714729765288
- Lot Numbers
327599003275990332789717 327897183282962932847692 328484813289806732919347 329271953294948032956257 329573023296507232985475 329879613304792833145976 331459783320804633208048 3324262633275535
- Amount recalled
- 305 units
This recall covers 31 products
The agency filed one notice per product. You are reading one of them; the other 30 are below.
18 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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