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Wallflex™ esophageal fully covered partially covered stent systems
Official notice
21 Aug 2024
An official Health Canada notice concerns Wallflex™ esophageal fully covered partially covered stent systems. Boston Scientific is initiating a removal of certain lots of the WallFlex™ Esophageal Stent System due to the potential for delivery catheter tip detachment. An investigation found that this observation was due to process variation for specific lots. Boston Scientific has addressed and corrected this finding in the manufacturing process. Recall start date: August 1, 2024 Published 2024-08-21.
What to do now
Contact the manufacturer if you require additional information.
Recall number
75955
Official notice
2024-08-21
The hazard
The hazard
Boston Scientific is initiating a removal of certain lots of the WallFlex™ Esophageal Stent System due to the potential for delivery catheter tip detachment. An investigation found that this observation was due to process variation for specific lots. Boston Scientific has addressed and corrected this finding in the manufacturing process. Recall start date: August 1, 2024
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Turn on recall alertsAffected products
Affected products
Product 1
Product 2
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Manufacturer
Phone
Brand: Boston Scientific, Wallflex™ Esophageal Fully Covered Partially Covered Stent.
Source & status
Source & status
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Tier
Category
Classification
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Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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