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Wallflex™ esophageal fully covered partially covered stent systems

Official notice

21 Aug 2024

Last checked

21 Aug 2024

Medium riskHealth Canada
Watch Boston Scientific

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

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

Compare the VIN on your vehicle against the official list. If your VIN is listed, follow the official notice.

Recall Numbers

75955

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Affected products

Product 1

Affected products - WallFlex™ Esophageal Fully Covered Rmv Stent System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - M00516250 M00516260 M00516210 M00516220

Product 2

Affected products - WallFlex™ Esophageal Partially Covered Stent System, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - M00516910 M00516930 M00516900 M00516940 M00516920 M00516950

Risk / 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

Where it was sold

The source does not list specific retailers. See the official notice for where affected vehicles were sold.

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Brand

Boston Scientific, Wallflex™ Esophageal Fully Covered Partially Covered Stent

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Wallflex™ Esophageal Fully Covered Partially Covered Stent.

Source & status

Source

Health Canada

Tier

official

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

75955

Classification

Type II

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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