INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers
Brand(s)
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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