LivaNova USA Inc.
Medical device manufacturer in Houston, TX.
3510(k) clearances
2PMA approvals
48recalls
510(k) clearances
PMA approvals
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1068-2025 Class II | Brand Name: SenTiva DUO" Product Name: VNS Therapy SenTiva DUO", Model 1000-D…Their is a potential that implanted pulse generators may stop delivering therapy due to an internal… | 01/03/2025Open, Classified |
| Z-1067-2025 Class II | Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Catalog…Their is a potential that implanted pulse generators may stop delivering therapy due to an internal… | 01/03/2025Open, Classified |
| Z-1073-2025 Class II | SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst…Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated… | 12/12/2024Open, Classified |
| Z-1072-2025 Class II | SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System.…Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated… | 12/12/2024Open, Classified |
| Z-0532-2022 Class II | Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20…A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be… | 12/02/2021Terminated |
| Z-0535-2021 Class II | VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic…During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model… | 11/12/2020Terminated |
| Z-0462-2021 Class II | VNS Therapy AspireSR GeneratorDue to an extra digit being inadvertently added to the serial number of a subset of implantable pulse… | 09/28/2020Terminated |
| Z-2464-2020 Class II | Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2463-2020 Class II | Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2462-2020 Class II | 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2461-2020 Class II | 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2460-2020 Class II | 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2459-2020 Class II | 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285XXX | 04/24/2020Terminated |
| Z-2458-2020 Class II | 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2457-2020 Class II | Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2456-2020 Class II | Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2455-2020 Class II | Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2454-2020 Class II | Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2453-2020 Class II | Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2452-2020 Class II | Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2451-2020 Class II | Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2450-2020 Class II | Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2449-2020 Class II | Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2448-2020 Class II | Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2447-2020 Class II | Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2446-2020 Class II | Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2445-2020 Class II | Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2444-2020 Class II | Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-2443-2020 Class II | Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Insert…The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone… | 04/24/2020Terminated |
| Z-1498-2020 Class II | LivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to…The firm is providing validated cleaning and disinfection instructions in their revised operating… | 02/24/2020Terminated |
| Z-1563-2020 Class II | VNS Therapy Programmer, Model 3000 used with Models 103, 104, 105, 106, or 8103 VNS…False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2)… | 02/04/2020Open, Classified |
| Z-2642-2020 Class III | LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per caseSome packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2… | 11/18/2019Terminated |
| Z-0561-2020 Class I | VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve…Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but… | 08/22/2019Terminated |
| Z-1118-2020 Class II | VNS Therapy SENTIVA Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator…Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which… | 08/13/2019Terminated |
| Z-1389-2020 Class III | LivaNova SMART PERFUSION PACK INSPIRE 8S - Product Usage: The affected product is a…Perfusion tubing pack was packaged with the incorrect cuvette. | 07/03/2019Terminated |
| Z-1119-2020 Class III | LivaNova Sorin Connect DPIII KOMPL. S5 REF 96-415-130, 2017-08-15, IPX1, RXOnly…Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the… | 01/28/2019Terminated |
| Z-0869-2020 Class II | Cyberonics VNS Therapy AspireSR, Model 106 Generator, 26-0007-8400/1. The firm name on…This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature… | 11/16/2018Terminated |
| Z-0868-2020 Class II | Cyberonics VNS Therapy AspireHC Model 105 Generator, 26-0007-4000/3. The firm name on…This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature… | 11/16/2018Terminated |
| Z-0663-2020 Class II | VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnlyThis recall is being initiated due to reports that that the therapy programming tablet with software version… | 11/16/2018Open, Classified |
| Z-0346-2020 Class II | The LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an…Lead impedance values reported by the affected VNS generator will be higher compared to those reported by… | 11/16/2018Open, Classified |
| Z-0770-2019 Class II | Perfusion Pack, Rx only, Sterile EO4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in… | 11/09/2018Terminated |
| Z-0220-2020 Class II | SORIN Heater-Cooler System 3T 120V~/60Hz REF 16-02-85 Description of product: The…The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to… | 11/01/2018Terminated |
| Z-1099-2019 Class II | SORIN Heater-Cooler System 3T, REF 16-02-85 Intended for use with a Stockert/Sorin…For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). | 09/14/2018Terminated |
| Z-1901-2018 Class II | Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #:…Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert… | 04/20/2018Terminated |
| Z-1919-2018 Class II | Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The…Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique… | 03/13/2018Terminated |
| Z-1918-2018 Class II | Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The…Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique… | 03/13/2018Terminated |
| Z-2572-2018 Class II | VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. | 01/24/2018Terminated |
| Z-0664-2018 Class III | Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx.…The product is labeled with the incorrect expiration date. | 12/19/2017Terminated |