VNS Therapy SENTIVA DUO # 1000-D - Product Usage recall
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a…
Why was VNS Therapy SENTIVA DUO # 1000-D - Product Usage recalled?
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348
- Product
- VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a…
- Recalling firm
- LivaNova USA Inc
- Quantity
- 8 generators
- Distribution
- International distribution in the countries of Austria and United Kingdom.
- Recall date
- December 16, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)