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Accolade™ mri pacemaker

Official notice

24 Sept 2024

HighHealth Canada

An official Health Canada notice concerns Accolade™ mri pacemaker. Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use. Recall start date: September 12, 2024 Published 2024-09-24.

What to do now

Contact the manufacturer if you require additional information.

Recall number

76188

Official notice

2024-09-24

The hazard

Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use. Recall start date: September 12, 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

76188

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Affected products

Product 1

Affected products - ACCOLADE™ MRI Pacemaker, Lot or serial number - More than 10 numbers, contact manufacturer., Model or catalog number - L331

Risk / hazard

Boston Scientific is retrieving specific model l331 ACCOLADE™ pacemakers due to inadvertent re-use/duplication of certain model/serial number combinations. This duplication occurred during the manufacturing of devices built over the past month. There are no performance concerns with these pacemakers, and they have passed all manufacturing tests. Additionally, there have been no reported adverse events or patient harms related to their use. Recall start date: September 12, 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, Accolade™ Mri Pacemaker.

Source & status

Source

Health Canada

Tier

official

Category

HEALTH

Classification

Type I

App estimate

high

Recall details

Recall number

76188

Classification

Type I

Source tier

official

Documents, notices & source

See the official notice and source documents for full details.

View full official notice
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