Health product recall

ACCOLADE™ MRI Pacemaker

Last updated

Summary

Product
ACCOLADE™ MRI Pacemaker
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Affected products

Affected products

Lot or serial number

Model or catalog number

ACCOLADE™ MRI Pacemaker

More than 10 numbers, contact manufacturer.

L331

Issue

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Cardiovascular
Companies

Boston Scientific Corporation

4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798

Published by
Health Canada
Audience
General public
Healthcare
Recall class
Type I
Identification number
RA-76188

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