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Livanova VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy - safety alert
Official notice
1 Jan 2020
Last checked
1 Jan 2020
An official FDA notice concerns Livanova VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy - safety alert. An official FDA notice concerns VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy. The notice reports a chemical exposure risk. Follow the official notice for consumer instructions. Published 2020-01-01. Recall numbers: Z-0561-2020. Check the official notice for the complete list. Published 2020-01-01.
What to do now
The source does not provide specific consumer instructions. Follow the official FDA notice for next steps.
Units affected
1,687
Recall number
Z-0561-2020
Official notice
2020-01-01
The hazard
The hazard
An official FDA notice concerns VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy. The notice reports a chemical exposure risk. Follow the official notice for consumer instructions. Published 2020-01-01. Recall numbers: Z-0561-2020. Check the official notice for the complete list.
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
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Affected products
Product 1
Units affected
Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Affected area 2
Company & contacts
Company & contacts
Brand: Livanova. Contact: LivaNova USA Inc.
Source & status
Source & status
Recall details
Recall details
Recall number
Event id
Units affected
Status
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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