WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems
Brand(s)
Last updated
Summary
Product
WallFlex™ Esophageal Fully Covered/ Partially Covered Stent Systems
Issue
Medical devices - Performance
What to do
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 M00516260 M00516210 M00516220 |
| WallFlex™ Esophageal Partially Covered Stent System | More than 10 numbers, contact manufacturer. | M00516910 M00516930 M00516900 M00516940 M00516920 M00516950 |
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
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - General and plastic surgery
Health products - Medical devices - Gastroenterology and urology
Companies
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts, United States, 01752
Published by
Health Canada
Audience
General public
Healthcare
Industry
Recall class
Type II
Identification number
RA-75955
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