ClearanceBrief
Company ยท US

LivaNova USA Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2024 to 2026. Name variants (Inc, Corp, punctuation) are merged.

3510(k) clearances (1 in 12 months)
48recalls (0 in 12 months)
32recalls that name a 510(k)

Product codes

CodeDeviceRecords
DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass21
LYJStimulator, Autonomic Nerve, Implanted For Epilepsy15
DWFCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass5
DWCController, Temperature, Cardiopulmonary Bypass4
DWETubing, Pump, Cardiopulmonary Bypass3
DTZOxygenator, Cardiopulmonary Bypass2
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 11, 2026K250937Venous Return Cannulae
LivaNova USA, Inc.
DWF
Jul 10, 2025K250283RAP Femoral Venous Cannulae
LivaNova USA, Inc.
DWF
Aug 8, 2024K233702SMARxT Tubing and Connectors
LivaNova USA, Inc.
DWE

Latest recalls

DateFirm and productCodeLinked 510(k)
Jan 31, 2025LivaNova USA, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Open, Classified
LYJNone listed
Jan 31, 2025LivaNova USA, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Open, Classified
LYJNone listed
Jan 30, 2025LivaNova USA, Inc.
Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Ne
Open, Classified
LYJNone listed
Jan 30, 2025LivaNova USA, Inc.
Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: The LivaNova VNS Therapy" System, used for Vagus Nerve Stimula
Open, Classified
LYJNone listed
Dec 2, 2021LivaNova USA, Inc.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) and Model 303-30 PereniaDURA Lead (3.0 mm electrode inner diame
Terminated
LYJNone listed
Nov 12, 2020LivaNova USA Inc
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depress
Terminated
LYJNone listed
Sep 28, 2020LivaNova USA Inc
VNS Therapy AspireSR Generator
Terminated
LYJNone listed
Apr 24, 2020LivaNova USA Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Terminated
DWFK900753
Apr 24, 2020LivaNova USA Inc.
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
Terminated
DWFK900753
Apr 24, 2020LivaNova USA Inc.
1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Terminated
DTLNone listed
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
Terminated
DTLK833322
Apr 24, 2020LivaNova USA Inc.
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
Terminated
DTLK833322
Feb 24, 2020LivaNova USA Inc.
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 patient during cardiopulmonary bypass procedures last
Terminated
DWCK052601
Feb 4, 2020LivaNova USA Inc
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
Open, Classified
LYJNone listed
Dec 20, 2019LivaNova USA Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Terminated
LYJNone listed
Nov 18, 2019LivaNova USA Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Terminated
DTLK833322
Aug 13, 2019LivaNova USA Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-50
Terminated
LYJNone listed
Jul 3, 2019LivaNova USA Inc.
LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requiring extracorporeal support. The perfusion tubing packs includ
Terminated
DWEK981613
Jan 28, 2019LivaNova USA Inc.
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 perform, control and monitor extracorporeal blood circulat
Terminated
DTQK071318
Nov 16, 2018LivaNova USA Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Open, Classified
LYJNone listed
Nov 16, 2018LivaNova USA Inc
Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Terminated
LYJNone listed
Nov 16, 2018LivaNova USA Inc
Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus nerve stimulator.
Terminated
LYJNone listed
Nov 16, 2018LivaNova USA Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. Th
Open, Classified
LYJNone listed
Nov 9, 2018LivaNova USA
Perfusion Pack, Rx only, Sterile EO
Terminated
DWFK881330
Nov 1, 2018LivaNova USA Inc.
SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The Stckert Heater-Cooler System is an independent (i.e. independent of the water supply) 3-circuit-heating/cooling syste
Terminated
DWCK052601
Sep 14, 2018LivaNova USA Inc.
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 featuring a separate temperature control for extraco
Terminated
DWCK052601
May 18, 2018LivaNova USA
Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz
Terminated
DWCK052601
Mar 13, 2018LivaNova USA
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Holl
Terminated
DTZK130433
Mar 13, 2018LivaNova USA
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollo
Terminated
DTZK130209
Jan 24, 2018LivaNova USA Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Terminated
LYJNone listed
Dec 19, 2017LivaNova USA
Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
Terminated
DWEK981613
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