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Hot axios™ stent and electrocautery-enhanced delivery system

Official notice

23 Dec 2025

HighHealth Canada

An official Health Canada notice concerns Hot axios™ stent and electrocautery-enhanced delivery system. Boston Scientific is initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm). This action is being taken due to increased reports of stent deployment and expansion issues with these configurations. This issue only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this issue. Published 2025-12-23.

What to do now

Contact the manufacturer if you require additional information.

Recall number

81391

Official notice

2025-12-23

The hazard

Boston Scientific is initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm). This action is being taken due to increased reports of stent deployment and expansion issues with these configurations. This issue only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this issue.

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

M00553520, M00553530, M00553560

Other

RA RA-81391

Model Numbers

M00553520, M00553530, M00553560

Recall Numbers

81391

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Affected products

Product 1

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00553520

Product 2

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00553530

Product 3

Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalogue number - M00553560

Risk / hazard

Boston Scientific is initiating a removal of certain AXIOS™ Stent and Electrocautery Enhanced Delivery Systems (6 mm × 8 mm, 8 mm × 8 mm, and 20 mm × 10 mm). This action is being taken due to increased reports of stent deployment and expansion issues with these configurations. This issue only occurs at the time of delivery of the stent and is expected to be noticed by the physician. Successfully implanted stents are not affected by this issue.

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 I

App estimate

high

Recall details

Recall number

81391

Classification

Type I

Source tier

beta

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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