INGENIO, INLIVEN, INVIVE and VITALIO Pacemakers
Brand(s)
Summary
Contact the manufacturer if you require additional information.
Affected products
Affected products |
Lot or serial number |
Model or catalog number |
|---|---|---|
INGENIO Pacemaker |
00802526543289 |
K184 |
INLIVEN Cardiac Resynchronization Therapy - Pacemaker |
00802526536717 |
V285 |
INGENIO DR EL MRI Conditional Pacemaker |
00802526543715 |
K187 |
INVIVE Cardiac Resynchronization Therapy - Pacemaker |
More than 10 numbers, contact manufacturer. |
V182 |
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
Boston Scientific Corporation
4100 Hamline Avenue North, St. Paul, Minnesota, United States, 55112-5798
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