Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recallsee related information
Date Initiated by FirmDecember 12, 2024
Date PostedJanuary 31, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1072-2025
Recall Event ID 95435
PMA NumberP970003 
Product Classification Stimulator, autonomic nerve, implanted for epilepsy - Product Code LYJ
ProductSenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Code Information REF/UDI-DI: 1000/05425025750405, 1000-D/05425025750528 All Serial Numbers less than 500,000
Recalling Firm/
Manufacturer		 LivaNova USA, Inc.
100 Cyberonics Blvd
Houston TX 77058-2069
For Additional Information ContactLivaNova Customer Quality
866-882-8804
Manufacturer Reason
for Recall		Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizure frequency or depressive symptoms and in the longer term, patients may be required to undergo generator replacement surgery to replace their device.
FDA Determined
Cause 2		Device Design
ActionOn 12/12/2024, correction notices were mailed to customers asking them to do the following: 1. Monitor patient frequently and perform an on-demand System Diagnostic test at each visit per labeling (typical patient visit cadence is every 3-12 months). See VNS Therapy Physician s Manual, found in the Manuals Section https://www.livanova.com/epilepsy-vnstherapy/en-us/hcp/product-manuals or https://www.livanova.com/depression/en-us/healthcare-provider-resources. 2. Counsel prospective and current patients to ensure that they are aware of and understand the risks. You may elect to provide the patient letter. 3. Contact Customer Quality at 1-866-882-8804 (select option 1) or by e-mail at cservices@livanova.com if communication with the generator using the Programming System indicates that: i. Diagnostic tests cannot be performed ("Error Code 254 - Test Interrupted" error message) ii. System Diagnostic test displays a "LOW" lead impedance result. 4. Encourage patients to: i. Notify you if there is a change in perceived clinical symptoms (e.g. increase in seizures or depressive symptoms, etc.). ii. Notify you if they no longer perceive any form of stimulation. 5. Ensure that this notice is communicated to all personnel within your organization who need to be aware of it. 6. Complete and return the response form via email to M1000FieldAction@livanova.com Firm is updating the VNS Therapy Instructions for Use (IFU) to reflect the patient management recommendations relevant to this issue. Firm is also developing a design change to resolve the reed switch component issue for future generators. You will be notified when the devices with the design change are available (serial numbers greater than or equal to 500,000, currently targeted for release the second half of 2025). For questions contact the firm's Customer Quality at 1-866-882-8804, option 1 (Monday to Friday, 7 AM to 5 PM CST), or e-mail cservices@livanova.com
Quantity in Commerce72,280
DistributionUS: AK, AZ, CA, CO, CT, FL, GA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, PN, SC, SD, TN, TX, VA, VT, WA, WI, WV, UT. OUS: AE, AR, AT, BE, BG, BR, CA, CL, CO, CR, CZ, DE, DK, GR, HR, IL, IN, IT, JO, KW, LB, MK, NL, OM, PA, PE, PL, QA, RO, RS, SA, SE, SG, SI, TR, TT, UK, ZA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = LYJ
-
-