Z-0561-2020Class I

VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy

Name: Z-0561-2020 VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Creator: LivaNova USA Inc
Published: 2019-08-22
License: https://open.fda.gov/license/

LivaNova USA, Inc. / initiated 2019-08-22 / Terminated / root cause: design

FDA source

LivaNova USA Inc began a recall of VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy on 2019-08-22. FDA classified it as Class I and gives the reason as "Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to...". 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-0561-2020
Classification: Class I
Status: Terminated
Initiated: 2019-08-22
Posted: 2019-12-20
Terminated: 2024-03-28
Recalling firm: LivaNova USA, Inc.
Product: VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Product code: LYJ Stimulator, Autonomic Nerve, Implanted For Epilepsy
Reason for recall: Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additional surgery (premature replacement of generator), or patients may return to baseline seizure frequency or depressive symptoms due to cessation of intended stimulation.
Root cause tag: design
FDA root cause: Device Design
Action: On 08/22/19, Urgent Medical Device Correction notices were sent to customers including Neurosurgery, Risk Management, Neurology, and doctors. Doctors were asked to do the following: 1) Monitor the patient frequently and continue to perform diagnostic testing at each visit per labeling. Information and recommendations regarding device checks, resets and monitoring of clinical symptoms can be accessed in the physician's manual. 2) If the initial interrogation of the generator is found to be disabled unexpectedly (0mA output current), contact Customer Quality at (866) 882-8804 (Monday to Friday, 8 AM to 5 PM CST) or e-mail at [email protected]. 3) Ensure the patient does the following: a. (Epilepsy only) For patients that are able to do so and have Magnet Mode enabled, continue using their magnet regularly to verify that stimulation is felt as described by the labeling; and b. Notify their physician if there is a change in perceived clinical symptoms (e.g., increase in seizures/depressive symptoms, loss of perception of stimulation, etc.). 4) Please complete and return the attached Customer Response Form. Please return all potentially affected devices that remain in the hospital/facility inventory to the recalling firm. Further, a device update to resolve the issue in patient's devices is currently under development. The recalling firm will contact you as more information becomes available regarding this update. Please ensure that this notice is communicated to all personnel within your organization who need to be aware of it. Customers with additional questions are encouraged to call (866) 882-8804. On 10/08/19, Urgent Medical Device Correction notices were sent to doctors informing them that 1) Issue most likely to occur within first 60 days after enabling therapy, 2) Interrogate device at the end of titration visits (for new and replacement devices) to ensure settings remain programmed as intended, 3) Recalling firm is currently only distributing devices no
Quantity in commerce: 1687
Distribution: U.S.: MN, IL, AK, NY, FL, PA, AR, CA, NC, WI, AZ, KY, TX, MA, MT, NE, IA, WV, CO, AL, MI, LA, VA, OH, MO, IN, NJ, GA, TN, MS, DC, SC, CT, UT, OK, MD, ID, KS, DE, OR, ND, WA, NM, PR. OUS (foreign): AT, CH, DE, ES, FI, GB, IE, NL, NO, PT, SE, IT
Product codes and lots: Implanted devices with Serial Numbers Greater Than or Equal to 100000 that did not undergo the internal error screen.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0561-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0561-2020	Class I	Terminated	Voluntary: Firm initiated	2020-01-01	2019-12-20

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)