LivaNova USA, Inc.
43 recalls on record · Latest: Feb 12, 2025
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Agency notice ledger
Federal filing book LivaNova USA, Inc. MID-BOOK · SINGLE-AGENCY
#407 of 14,151 · 43 notices · 0.041% archive
- BOOK 43 notices
- RANK #407 of 14,151
- SHARE 0.041% archive
- AGENCY FDA Devices (43)
- CAT medical devices
- CATS 1 category
- LATEST Feb 12, 2025
- PHOTO Abbott Medical
Nearest notice-volume peer: Abbott Medical (0 notice gap)
LivaNova USA, Inc. accounts for about 0.041% of the 104,423-notice archive on 43 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
Where LivaNova USA, Inc. sits among 14,151 recalling firms
LivaNova USA, Inc. ranks 407th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
LivaNova USA, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
43 407th of 14151 higher than 13,739 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
LivaNova USA, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- LivaNova USA,… (this)
LivaNova USA, Inc.
43 notices
- Abbott Medical
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43 notices
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43 notices
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43 notices
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43 notices
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43 notices
What this shows LivaNova USA, Inc. holds about 0.041% of archive notices alongside 43 distinct filings.
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 5, 2025
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 Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is hous
FDA Devices Moderate Feb 5, 2025
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 Nerve Stimulation (VNS), consists of an implantable VNS Therapy generator, lead, and external programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The gener
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 303-30 PereniaDURA Lead (3.0 mm electrode inner diameter)
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 treatment-resistant or treatment- intolerant depressive episode.
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 Jul 8, 2020
Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
FDA Devices Moderate Jul 8, 2020
1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
FDA Devices Moderate Jul 8, 2020
1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
FDA Devices Moderate Jul 8, 2020
Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert Label:029165000/ 00803622123153
FDA Devices Moderate Jul 8, 2020
Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
FDA Devices Moderate Apr 1, 2020
VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS Therapy generators.
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 patient during cardiopulmonary bypass procedures lasting 6 hours or less.
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 extracorporeal support. The perfusion tubing packs include the cuvette used with equipment to monitor blood.
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 perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.
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 Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)
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 stimulator.
FDA Devices Moderate Feb 5, 2020
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.
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 programming system used to change stimulation settings. The generator is an implantable, multi-programmable pulse generator that delivers electrical signals to the vagus nerve through the lead. The generator is housed in a hermetically sealed titanium case and is powered by a single battery. Electrical signals are transmitted from the generator to the vagu
FDA Devices Moderate Nov 6, 2019
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. independent of the water supply) 3-circuit-heating/cooling system. The three separate water circuits have been developed to serve as: " Two circuits for the patient supplied by one tank (for the heating/cooling blanket and the heat-exchanger associated with the oxygenator), common temperatures ranging from 2 degrees Celsius to 41 degrees Celsius, tank volu
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 featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.
FDA Devices Moderate Aug 8, 2018
VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
LivaNova USA, Inc. holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (43 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name LivaNova USA, Inc.? ▼
PlainRecalls indexes 43 distinct federal recall events naming LivaNova USA, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does LivaNova USA, Inc. sit among other recalling firms? ▼
LivaNova USA, Inc. ranks #407 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of LivaNova USA, Inc.'s notices? ▼
FDA Devices accounts for 43 of this firm's 43 indexed notices.
What product category dominates LivaNova USA, Inc.'s filing book? ▼
Filings for LivaNova USA, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
LivaNova USA, Inc.: 43 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming LivaNova USA, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026