Livanova Usa recalls
Livanova Usa appears in 48 official U.S. recall notices indexed by RecallRadar, most recently on 2025-02-12.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
- SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa - Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog Number: 1000 Software Version: NA Product Description: T…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D Model/Catalog Number: 1000-D Software Version: NA Product De…
FDA Device · Class II · 2025-02-05 · Livanova Usa - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa - VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experi…
FDA Device · Class II · 2020-12-16 · Livanova Usa - VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2020-11-25 · Livanova Usa - LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA Device · Class III · 2020-07-29 · Livanova Usa - Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
FDA Device · Class II · 2020-07-08 · Livanova Usa - 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
FDA Device · Class II · 2020-07-08 · Livanova Usa - 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
FDA Device · Class II · 2020-07-08 · Livanova Usa - 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
FDA Device · Class II · 2020-07-08 · Livanova Usa - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
FDA Device · Class II · 2020-07-08 · Livanova Usa - 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
FDA Device · Class II · 2020-07-08 · Livanova Usa - Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
FDA Device · Class II · 2020-07-08 · Livanova Usa - VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators
FDA Device · Class II · 2020-04-01 · Livanova Usa - LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to circulate water through heat exchangers to warm or…
FDA Device · Class II · 2020-03-25 · Livanova Usa - LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a perfusion tubing pack use in surgical procedures requir…
FDA Device · Class III · 2020-03-04 · Livanova Usa - 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…
FDA Device · Class III · 2020-02-19 · Livanova Usa - VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depre…
FDA Device · Class II · 2020-02-19 · Livanova Usa - Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus ne…
FDA Device · Class II · 2020-02-05 · Livanova Usa - Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on the label is CYBERONICS, INC., Houston, TX. Vagus ner…
FDA Device · Class II · 2020-02-05 · Livanova Usa - VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Device · Class I · 2020-01-01 · Livanova Usa - VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
FDA Device · Class II · 2019-12-18 · Livanova Usa - The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and extern…
FDA Device · Class II · 2019-11-13 · Livanova Usa - SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The St¿ckert Heater-Cooler System is an independent (i.e. ind…
FDA Device · Class II · 2019-11-06 · Livanova Usa - 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…
FDA Device · Class II · 2019-04-17 · Livanova Usa - Perfusion Pack, Rx only, Sterile EO
FDA Device · Class II · 2019-01-30 · Livanova Usa - VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
FDA Device · Class II · 2018-08-08 · Livanova Usa - Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the o…
FDA Device · Class II · 2018-05-30 · Livanova Usa - Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the o…
FDA Device · Class II · 2018-05-30 · Livanova Usa - Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz
FDA Device · Class II · 2018-05-30 · 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…
FDA Device · Class III · 2018-02-28 · Livanova Usa