Z-0535-2021Class II

VNS Therapy SENTIVA DUO # 1000-D -

Name: Z-0535-2021 VNS Therapy SENTIVA DUO # 1000-D -
Creator: LivaNova USA Inc
Published: 2020-11-12
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2020-11-12 / Terminated / root cause: design

FDA source

LivaNova USA Inc began a recall of VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a... on 2020-11-12. FDA classified it as Class II and gives the reason as "During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0535-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-12
Posted: 2020-12-04
Terminated: 2023-01-12
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.
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.
Root cause tag: design
FDA 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 [email protected]. 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 [email protected].
Quantity in commerce: 8 generators
Distribution: International distribution in the countries of Austria and United Kingdom.
Product codes and lots: Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0535-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0535-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-16	2020-12-04

Product code LYJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)