FDA Medical Device Recalls (openFDA)
LivaNova USA Inc: VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
- Recall number
- Z-0535-2021
- Recalling firm
- LivaNova USA Inc
- Product
- VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.
- Status
- Terminated
- Initiated
- 2020-11-12
- Posted
- not on file
- Terminated
- 2023-01-12
- Reason
- During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
- Root cause
- Device Design
- Action
- On 10/09/2020, the firm hand-delivered an "URGENT: FIELD SAFETY NOTICE" informing its customers that in the event that a generator reset occurs (whether due to troubleshooting efforts or a device issue), the device will erroneously display the incorrect model number as "Model 1000 on the device In-Session programmer screen. The risk to patients could potentially be when the patient undergoes a future generator replacement surgery. Actions Physicians are to take: 1. Model 1000-D devices susceptible to this issue are provided in Attachment 1. When interrogating the generator and performing diagnostic testing per labeling, verify that the In-Session screen displays M1000-D. 2. If an interrogation of the generator is found to display M1000 In-Session or on the Session Report after interrogation, contact Customer Quality at (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or their local sales representative to report the event and for troubleshooting assistance. 3. To complete and return the attached Customer Response Form by fax to (281) 853-1248 or by e-mail to LivaNova.FSCA@livanova.com. The Recalling Firm is developing a device update that will eliminate the possibility for this erroneous model number display and expects that update to be available later in 2020. The Recalling Firm will contact its customers to schedule a visit to update the implanted device. For questions about this Medical Device Correction, contact Customer Quality at +1 (281) 228-7330 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at cservices@LivaNova.com.
- Quantity
- 8 generators
- Distribution
- International distribution in the countries of Austria and United Kingdom.
- Lot, serial or model codes
- Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LYJ
- Firm FEI
- 1000117004
- Firm city
- Houston
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28