Reported Oct 2, 2024 · Ongoing
WALLFLEX PC ESOPH STENT 18/23MM X 103MM- 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 18/23MM X 103MM- 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)M00516900
- Lot codes and dates
- GTIN08714729765240
- Lot Numbers
327599023278016032830094328659763286855732875121328910293289806532898066329064143291574532938540 329660043297768232985473330267023302670433036452330364533304596433056440331197313312091333167136 331692653316926633169267
- Amount recalled
- 297 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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