Health product recall

INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers

Last updated

Summary

Product
INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers
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
INGENIO Pacemaker 00802526543289 00802526509698 00802526509704 00802526543685 00802526509711 00802526536915 00802526536809 K184
INLIVEN Cardiac Resynchronization Therapy - Pacemaker 00802526536717 00802526543395 V285
INGENIO DR EL MRI Conditional Pacemaker 00802526543715 00802526535956 00802526543319 K187
INVIVE Cardiac Resynchronization Therapy - Pacemaker More than 10 numbers, contact manufacturer. V182 V183
VITALIO Pacemaker 00802526536571 K284

Issue

Field Safety Notice was initiated due to the potential for the INGENIO family to exhibit a high battery impedance later in device life and initiate safety mode. Most safety mode reports continue to be associated with telemetry operations with a small percentage unrelated to interrogations by an external device.

Recall Start Date: November 30, 2023

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
Healthcare
Recall class
Type I
Identification number
RA-74765

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