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.
Recall summary
| Recall notices | 48 |
|---|---|
| Published | 2018-02-28 to 2025-02-12 |
| By agency | FDA Device (48) |
| By classification | Class II (43), Class III (4), Class I (1) |
| By status | terminated (41), ongoing (7) |
| Distribution named in notices | AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, US, UT, VA, VT, WA, WI, WV, WY |
Recalls
- SenTiva, REF: 1000
FDA Device · Class II · 2025-02-12 · Livanova Usa
Reason: Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizu… - SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation
FDA Device · Class II · 2025-02-12 · Livanova Usa
Reason: Vagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a closed position, which may result in patients returning to baseline seizu… - 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
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. - 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
Reason: Their is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. - Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303
FDA Device · Class II · 2022-02-09 · Livanova Usa
Reason: A manufacturing issue may cause the silicone tubing wall thickness of vagus nerve stimulation leads to be less than the design specification. If the tubing becomes completely breached, the patient may experience discomf… - 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
Reason: During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated. - VNS Therapy¿ AspireSR¿ Generator
FDA Device · Class II · 2020-11-25 · Livanova Usa
Reason: Due to an extra digit being inadvertently added to the serial number of a subset of implantable pulse generators, they become not compatible with therapy programmers with software version 11.0.4. - LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
FDA Device · Class III · 2020-07-29 · Livanova Usa
Reason: Some packages of sterile disposable connectors contained a 3/8x1/4 reducer instead of the specified 1/2x1/2 connector. No significant risk to health is expected as the issue is easily detectable and the different shape… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 3/8 STR CONN, STRL REF/ GTIN for Insert Label:EC2130S/ 00803622129292
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 1/4X3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2140S/ 00803622129315
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 1/2 - 3/8 REDUC CONN, STRL REF/ GTIN for Insert Label:EC2145S/ 00803622129322
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Vein Irrigation Cannula with blunt tip
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 3/8X3/8X3/8 Y CONN, STRL REF/ GTIN for Insert Label:EC2105S/ 00803622129285
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: XXX - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24
FDA Device · Class II · 2020-07-08 · Livanova Usa
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: The firm has identified through internal tests that the sterile barrier of certain Sterile Standalone Connectors may present a breach. The issue potentially affects component assembled with a specific packaging and is a… - 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
Reason: False positive warning may occur after: 1) VNS Generator interrogated at 0mA normal output current, 2) Generator programmed to non-0mA output current, 3) In-session re-interrogation performed. Users instructed to lower… - 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
Reason: The firm is providing validated cleaning and disinfection instructions in their revised operating instructions to reduce the risk of NTM contamination. - 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
Reason: Perfusion tubing pack was packaged with the incorrect cuvette. - 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
Reason: Incorrect labeling; it was identified that some Datapad devices contained incorrect labels. Specifically the manufacturing date in the production identifier was incorrect and the manufacturing date on the unique device… - 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
Reason: Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications. - 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
Reason: This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 gene… - 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
Reason: This recall is an expansion of Z-3019-2017 and Z-3020-2017, which was initiated to fix the devices premature battery depletion, caused by electrical leakage on the circuit board assemblies of the Models 105 and 106 gene… - VNS Therapy, SenTiva, Model # 1000, (01)05425025750405, Rx Only for vagal nerve stimulation (VNS) therapy
FDA Device · Class I · 2020-01-01 · Livanova Usa
Reason: Sentiva generators may reset and become disabled within 60 days of enabling. Physicians can re-enable but devices will continue to be susceptible to resets. If a device experiences this issue, this may lead to additiona… - VNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnly
FDA Device · Class II · 2019-12-18 · Livanova Usa
Reason: This recall is being initiated due to reports that that the therapy programming tablet with software version 1.5 errantly performs a normal mode diagnostic test instead of the selected system diagnostic test on Model 10… - 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
Reason: Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance me… - 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
Reason: The firm has become aware that due to a chemical reaction, the disinfectant/water preservative used to disinfect the device to inhibit/limit the growth micro-organisms, may be rendered ineffective. In addition, the firm… - 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
Reason: For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM). - Perfusion Pack, Rx only, Sterile EO
FDA Device · Class II · 2019-01-30 · Livanova Usa
Reason: 4-way stopcocks and stopcock manifold assembled in certain perfusion tubing systems, indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours, may leak or be occluded. - VNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2
FDA Device · Class II · 2018-08-08 · Livanova Usa
Reason: Unintended warning message displayed on generators programmed with a Model 3000 v.1.0.2.2 programmer. - 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
Reason: Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration da… - 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
Reason: Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration da… - Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz
FDA Device · Class II · 2018-05-30 · Livanova Usa
Reason: Firm is notifying customers that the Deep-Cleaning Service is now available in the United States. Stockert Heater-Cooler System 3T devices are suspected of microbial contamination and may contain visible biofilm. - 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
Reason: The product is labeled with the incorrect expiration date.