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Cre™ wireguided and cre pro™ wireguided balloon dilation catheters

Official notice

29 May 2026

MediumHealth Canada

An official Health Canada notice concerns Cre™ wireguided and cre pro™ wireguided balloon dilation catheters. Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract. Published 2026-05-29.

What to do now

Contact the manufacturer if you require additional information.

Recall number

82136

Official notice

2026-05-29

The hazard

Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.

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.

Skus

M00558680, M00558690, M00558660, M00558670, M00558700, M00558710

Other

RA RA-82136

Model Numbers

M00558680, M00558690, M00558660, M00558670, M00558700, M00558710

Recall Numbers

82136

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558680

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558690

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558660

Product 4

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558670

Product 5

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558700

Product 6

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00558710

Risk / hazard

Boston Scientific is initiating removal of CRE™ Wireguided and CRE PRO™ Wireguided balloon dilation catheters due to a potential sterile breach of the pouches in which the devices are packaged. These catheter products are primarily used to endoscopically dilate strictures of the alimentary tract.

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.

Source & status

Source

Health Canada

Tier

beta

Category

HOME

Classification

Type II

App estimate

medium

Recall details

Recall number

82136

Classification

Type II

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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