Health product recall

Emblem MRI S-ICD PG

Last updated

Summary

Product
Emblem MRI S-ICD PG
Issue
Medical devices - Performance issue
What to do

Contact the manufacturer if you require additional information.

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalog number

Emblem MRIi S-ICD PG

169286

A219

Issue

A subset of Emblem S-ICDs was manufactured in September and has an incorrect date/timestamp which may cause an inaccurate display of battery capacity. The device's manufacturing date/timestamp is used by the programmer and latitude™ patient management system to calculate and display the battery capacity. The battery capacity value is intended to decrement in a linear manner over the device's implant life. For devices with an incorrect manufacturing date/timestamp, the initial battery capacity displayed after exiting storage mode is approximately 10%. This displayed battery capacity behavior does not affect the device's performance (i.e., ability to detect/treat arrythmias) or the actual battery longevity.

Recall start date: October 3, 2022. 

Additional information

Details
Original published date: 2022-11-09
Alert / recall type
Health product recall
Category
Health product - Medical device - Cardiovascular
Companies

Boston Scientific Corporation

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

Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-72171