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Expo angiographic catheters

Official notice

3 Apr 2024

MediumHealth Canada

An official Health Canada notice concerns Expo angiographic catheters. Boston Scientific initiated a removal of certain batches of Expo 5F angiographic catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device. Our internal investigation has revealed that there is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. Recall start date: March 21, 2024 Published 2024-04-03.

What to do now

Contact the manufacturer if you require additional information.

Recall number

75327

Official notice

2024-04-03

The hazard

Boston Scientific initiated a removal of certain batches of Expo 5F angiographic catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device. Our internal investigation has revealed that there is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. Recall start date: March 21, 2024

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.

Recall Numbers

75327

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Affected products

Product 1

Affected products - Expo Angiographic Catheters-Multipack Family, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - H749085263012

Risk / hazard

Boston Scientific initiated a removal of certain batches of Expo 5F angiographic catheters due to an increase in complaints related to an inability to advance the guidewire through the lumen of the device. Our internal investigation has revealed that there is evidence of the polyurethane layer delaminating and in some instances material detachment in the catheters inner lining. Recall start date: March 21, 2024

Where it was sold

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

Location 1

CA · Canada

Affected area 1

CA · Canada

Company & contacts

Manufacturer

Not provided

Phone

Not provided

Brand: Boston Scientific, Expo Angiographic Catheters.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type II

App estimate

medium

Recall details

Recall number

75327

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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