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Health Canada Medical devices

WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems

Issued August 21, 2024
Issue
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
Hazard description
Performance
Product
Product name
WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems
Reference
ID
RA-75955