Brand

Livanova Usa Inc. Recalls

26 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Livanova Usa Inc..

26Total Recalls
1Critical
108,433Units Affected
Dec 12, 2024Most Recent
All Recalls

Every Livanova Usa Inc. Recall

Sorted by most recent. Click any recall for full details.

26 recalls
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·81,606 affected·Dec 12, 2024
High RiskFDA
Livanova Usa, Inc.
SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Medical Devices·48 affected·Dec 12, 2024
High RiskFDA
Livanova Usa, Inc.
Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 PereniaDURA Lead (2.0 mm electrode inner diameter) ...
Medical Devices·10 affected·Dec 2, 2021
High RiskFDA
Livanova Usa Inc
VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are expe...
Medical Devices·8 affected·Nov 12, 2020
High RiskFDA
Livanova Usa Inc
VNS Therapy¿ AspireSR¿ Generator
Medical Devices·134 affected·Sep 28, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
Medical Devices·240 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
Medical Devices·325 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
Medical Devices·768 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
Medical Devices·48 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
Medical Devices·72 affected·Apr 24, 2020
High RiskFDA
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
Medical Devices·984 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
Medical Devices·24 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
Medical Devices·220 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
Medical Devices·420 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
Medical Devices·860 affected·Apr 24, 2020
High RiskFDA
Livanova Usa Inc.
Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
Medical Devices·600 affected·Apr 24, 2020
High RiskFDA
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 ...
Medical Devices·9,309 affected·Feb 24, 2020
RecallFDA
Livanova Usa Inc.
LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
Medical Devices·140 affected·Nov 18, 2019
CriticalFDA
Livanova Usa Inc
VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
Medical Devices·1,687 affected·Aug 22, 2019
High RiskFDA
Livanova Usa Inc
VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual f...
Medical Devices·6 affected·Aug 13, 2019
RecallFDA
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 u...
Medical Devices·5 affected·Jan 28, 2019
High RiskFDA
Livanova Usa Inc
VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
Medical Devices·643 affected·Nov 16, 2018
High RiskFDA
Livanova Usa Inc
The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and exte...
Medical Implants·9,282 affected·Nov 16, 2018
High RiskFDA
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. Vag...
Medical Devices·745 affected·Nov 16, 2018
High RiskFDA
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-...
Cardiac Devices·6 affected·Sep 14, 2018
High RiskFDA
Livanova Usa Inc
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
Medical Devices·243 affected·Jan 24, 2018