WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems
In plain language
This recall involves WallFlex Esophageal Fully Covered and Partially Covered Stent Systems sold in Canada. They are being recalled because the delivery catheter tip may detach. Contact the manufacturer for more information.
What to do
- Contact the manufacturer for additional information.
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Affected products
WallFlex Esophageal Fully Covered Rmv Stent System
Model: M00516210, M00516220, M00516250, M00516260
Lot: More than 10 numbers, contact manufacturer.
WallFlex Esophageal Partially Covered Stent System
Model: M00516900, M00516910, M00516920, M00516930, M00516940, M00516950
Lot: More than 10 numbers, contact manufacturer.
Why this matters
Delivery catheter tip detachment
Do I have this product?
This recall only applies to specific products. Follow the steps below to check.
- 1
Check the product name
Make sure your product name matches one of the affected products listed above.
- 2
Check the lot number
Lot numbers identify specific production batches.
Affected lots: More than 10 numbers, contact manufacturer.
- 3
Check the model number
Model numbers are typically on the product label or packaging.
Affected models: M00516210, M00516220, M00516250, M00516260, M00516900, M00516910, M00516920, M00516930, M00516940, M00516950
If your product matches one or more of the details above, it may be affected by this recall.
If your product does not match these details, it is not affected by this recall.
When in doubt, always check the official notice.
Frequently Asked Questions
Why was this product recalled?
Delivery catheter tip detachment
What should consumers do?
Contact the manufacturer for additional information.
Where was the product sold?
This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.
Is there a health risk?
Yes, there may be a health risk. Delivery catheter tip detachment
When was this product recalled?
This product was recalled on August 21, 2024.
Is the BOSTON SCIENTIFIC CORPORATION brand affected by this recall?
Yes, BOSTON SCIENTIFIC CORPORATION products are affected by this recall. This recall involves WallFlex Esophageal Fully Covered and Partially Covered Stent Systems sold in Canada. They are being recalled because the delivery catheter tip may detach. Contact the manufacturer for more information.