Health product recall

INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers

Last updated

Summary

Product
INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers
Issue
Medical devices - Performance
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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