ACCOLADE™ MRI Pacemaker
Brand(s)
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
Get notified
Receive notifications for new and updated recalls and alerts by category.