LivaNova USA Inc.
28 recalls on record · Latest: Feb 12, 2025
FDA Devices Moderate Feb 12, 2025
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
FDA Devices Moderate Feb 12, 2025
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
FDA Devices Moderate Feb 9, 2022
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 30…
FDA Devices Moderate Dec 16, 2020
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a t…
FDA Devices Moderate Nov 25, 2020
VNS Therapy¿ AspireSR¿ Generator
FDA Devices Low Jul 29, 2020
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
FDA Devices Moderate Jul 8, 2020
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
FDA Devices Moderate Jul 8, 2020
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
FDA Devices Moderate Jul 8, 2020
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
FDA Devices Moderate Jul 8, 2020
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
FDA Devices Moderate Mar 25, 2020
LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or cool a pa…
FDA Devices Low Mar 4, 2020
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extrac…
FDA Devices Low Feb 19, 2020
LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly, (01)04033817901594 Product Usage: The S5 System is used to perfo…
FDA Devices Moderate Feb 19, 2020
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depressio…
FDA Devices Moderate Feb 5, 2020
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve sti…
FDA Devices Critical Jan 1, 2020
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Devices Moderate Dec 18, 2019
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
FDA Devices Moderate Nov 13, 2019
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external program…
FDA Devices Moderate Apr 17, 2019
SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine…
FDA Devices Moderate Aug 8, 2018