LivaNova USA, Inc.
LivaNova USA, Inc. appears in FDA public data with 48 recalls — including 1 Class I (most serious) —, 3 510(k) clearances, 10 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1068-2025, Class II) was initiated on January 3, 2025. Its most recent 510(k) clearance was granted on March 11, 2026.
Summary
- Total Recalls
- 48 (1 Class I)
- 510(k) Clearances
- 3
- Inspections
- 10
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1068-2025 | Class II | Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Numbe | January 3, 2025 |
| Z-1067-2025 | Class II | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 S | January 3, 2025 |
| Z-1072-2025 | Class II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for | December 12, 2024 |
| Z-1073-2025 | Class II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used fo | December 12, 2024 |
| Z-0532-2022 | Class II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Le | December 2, 2021 |
| Z-0535-2021 | Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurren | November 12, 2020 |
| Z-0462-2021 | Class II | VNS Therapy¿ AspireSR¿ Generator | September 28, 2020 |
| Z-2443-2020 | Class II | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 0 | April 24, 2020 |
| Z-2450-2020 | Class II | Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622 | April 24, 2020 |
| Z-2464-2020 | Class II | Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 0080 | April 24, 2020 |
| Z-2444-2020 | Class II | Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 | April 24, 2020 |
| Z-2454-2020 | Class II | Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00 | April 24, 2020 |
| Z-2463-2020 | Class II | Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803 | April 24, 2020 |
| Z-2448-2020 | Class II | Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 0 | April 24, 2020 |
| Z-2452-2020 | Class II | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00 | April 24, 2020 |
| Z-2456-2020 | Class II | Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 008 | April 24, 2020 |
| Z-2449-2020 | Class II | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00 | April 24, 2020 |
| Z-2457-2020 | Class II | Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803 | April 24, 2020 |
| Z-2446-2020 | Class II | Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 0080 | April 24, 2020 |
| Z-2453-2020 | Class II | Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803 | April 24, 2020 |