LivaNova USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
48 (1 Class I)
510(k) Clearances
3
Inspections
10
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1068-2025Class IIBrand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog NumbeJanuary 3, 2025
Z-1067-2025Class IIBrand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 SJanuary 3, 2025
Z-1072-2025Class IISenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used forDecember 12, 2024
Z-1073-2025Class IISenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used foDecember 12, 2024
Z-0532-2022Class IIVagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA LeDecember 2, 2021
Z-0535-2021Class IIVNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrenNovember 12, 2020
Z-0462-2021Class IIVNS Therapy¿ AspireSR¿ GeneratorSeptember 28, 2020
Z-2450-2020Class IISterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622April 24, 2020
Z-2451-2020Class IISterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00April 24, 2020
Z-2446-2020Class IISterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 0080April 24, 2020
Z-2457-2020Class IISterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803April 24, 2020
Z-2449-2020Class IISterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00April 24, 2020
Z-2444-2020Class IISterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 April 24, 2020
Z-2452-2020Class IISterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00April 24, 2020
Z-2443-2020Class IISterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 0April 24, 2020
Z-2463-2020Class IIVein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803April 24, 2020
Z-2456-2020Class IISterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 008April 24, 2020
Z-2453-2020Class IISterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803April 24, 2020
Z-2464-2020Class IIVein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 0080April 24, 2020
Z-2445-2020Class IISterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 0April 24, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K250937Venous Return CannulaeMarch 11, 2026
K250283RAP Femoral Venous CannulaeJuly 10, 2025
K233702SMARxT Tubing and ConnectorsAugust 8, 2024