Public recall detail

VNS Therapy SenTiva Generators

2025-02-05

medium
Recall Safety notice
Quick summary

Quick summary: VNS Therapy SenTiva Generators. Date: 2025-02-05.

Recommended action

Recommended action: compare your product with the official notice and follow the instructions published by the official source.

Recall details

Quick summary: VNS Therapy SenTiva Generators. Date: 2025-02-05.

Official details

Affected product details

Structured information extracted from the official recall notice. Confirm the identifiers and instructions in the original notice.

BrandLivanova Usa, Inc.
ProductVNS Therapy SenTiva Generators
IssueMedical devices - Performance
Recall classType II
IdentificationRA-76909

Affected products

ProductVNS Therapy SenTiva Generators
LotMore than 10 numbers, contact manufacturer.
Model1000
Serial numberMore than 10 numbers, contact manufacturer.
DescriptionVNS Therapy SenTiva Generators

Issue

Complaints have been received where the SenTiva generator is reporting a loss of therapy or inability to make therapy changes with the VNS therapy programming system. A reed switch malfunction, resulting in the reed switch sticking in a closed position has been identified as the cause of these device events. Recall start date: January 10, 2025

What you should do

  • Customers to be notified. Instructions to follow on response.
Additional official information
AudienceHealthcare
CategoryHealth products - Medical devices - Neurology
CompaniesLivanova Usa, Inc. 100 Cyberonics Blvd., Houston, Texas, United States, 77058
Published byHealth Canada
Recall classType II
Alert / recall typeHealth product recall
Identification numberRA-76909
Background{}
CompaniesLivanova Usa, Inc. 100 Cyberonics Blvd., Houston, Texas, United States, 77058
AudiencesHealthcare
Source updated2025-02-05

Contains information licensed under the Open Government Licence – Canada. SafetyPulse is independent of the Government of Canada.

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