WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
WallFlex™ Esophageal Fully Covered Rmv Stent System |
More than 10 numbers, contact manufacturer. |
M00516250 |
WallFlex™ Esophageal Partially Covered Stent System |
More than 10 numbers, contact manufacturer. |
M00516910 |
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
Additional information
Details
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
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