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
| Code | Device | Records |
|---|---|---|
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 21 |
| LYJ | Stimulator, Autonomic Nerve, Implanted For Epilepsy | 15 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 5 |
| DWC | Controller, Temperature, Cardiopulmonary Bypass | 4 |
| DWE | Tubing, Pump, Cardiopulmonary Bypass | 3 |
| DTZ | Oxygenator, Cardiopulmonary Bypass | 2 |
| DTQ | Console, Heart-Lung Machine, Cardiopulmonary Bypass | 1 |
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 31, 2025 | LivaNova USA, Inc. SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation.
Used for Vagus Nerve Stimulation (VNS). Open, Classified |
LYJ | None listed |
| Jan 31, 2025 | LivaNova 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 |
LYJ | None listed |
| Jan 30, 2025 | LivaNova 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 |
LYJ | None listed |
| Jan 30, 2025 | LivaNova 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 |
LYJ | None listed |
| Dec 2, 2021 | LivaNova 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 |
LYJ | None listed |
| Nov 12, 2020 | LivaNova 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 |
LYJ | None listed |
| Sep 28, 2020 | LivaNova USA Inc VNS Therapy AspireSR Generator Terminated |
LYJ | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107 Terminated |
DWF | K900753 |
| Apr 24, 2020 | LivaNova USA Inc. Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091 Terminated |
DWF | K900753 |
| Apr 24, 2020 | LivaNova USA Inc. 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova 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 |
DTL | K833322 |
| Apr 24, 2020 | LivaNova 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 |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290 Terminated |
DTL | None listed |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000
/ 00803622123184 Terminated |
DTL | K833322 |
| Apr 24, 2020 | LivaNova USA Inc. Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153 Terminated |
DTL | K833322 |
| Feb 24, 2020 | LivaNova 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 |
DWC | K052601 |
| Feb 4, 2020 | LivaNova USA Inc VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators. Open, Classified |
LYJ | None listed |
| Dec 20, 2019 | LivaNova USA Inc VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy Terminated |
LYJ | None listed |
| Nov 18, 2019 | LivaNova USA Inc. LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case Terminated |
DTL | K833322 |
| Aug 13, 2019 | LivaNova 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 |
LYJ | None listed |
| Jul 3, 2019 | LivaNova 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 |
DWE | K981613 |
| Jan 28, 2019 | LivaNova 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 |
DTQ | K071318 |
| Nov 16, 2018 | LivaNova USA Inc VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly Open, Classified |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Nov 16, 2018 | LivaNova 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 |
LYJ | None listed |
| Nov 9, 2018 | LivaNova USA Perfusion Pack, Rx only, Sterile EO Terminated |
DWF | K881330 |
| Nov 1, 2018 | LivaNova 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 |
DWC | K052601 |
| Sep 14, 2018 | LivaNova 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 |
DWC | K052601 |
| May 18, 2018 | LivaNova 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 |
DWC | K052601 |
| Mar 13, 2018 | LivaNova 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 |
DTZ | K130433 |
| Mar 13, 2018 | LivaNova 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 |
DTZ | K130209 |
| Jan 24, 2018 | LivaNova USA Inc VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2 Terminated |
LYJ | None listed |
| Dec 19, 2017 | LivaNova 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 |
DWE | K981613 |