The Recall Desk

Manufacturer

LivaNova USA, Inc.

43 recalls in our database name LivaNova USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
0
Severe
3
Most recent
2025-02-12

Of the 43 recalls from LivaNova USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (7%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 43

  • HighFDA (Devices)·Z-1072-2025·2025-02-12

    VNS Therapy Generators May Stop Delivering Stimulation Due to Component Failure

    The SenTiva and SenTiva Duo vagus nerve stimulation generators may stop delivering therapy due to an internal mechanical component becoming stuck, causing potential loss of seizure and depression control.

    Product
    SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy System. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1073-2025·2025-02-12

    VNS Therapy Generator May Stop Delivering Stimulation Due to Mechanical Defect

    LivaNova's SenTiva VNS generators (48 units) may stop delivering stimulation due to a mechanical defect. Patients may experience return to baseline seizure or depressive symptoms and may require replacement surgery.

    Product
    SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
    Category
    Medical Device
    Distribution
    41 states
  • HighFDA (Devices)·Z-1067-2025·2025-02-05

    Implantable VNS Therapy Generators May Stop Delivering Treatment

    LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.

    Product
    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 exte
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1068-2025·2025-02-05

    Implantable Vagus Nerve Stimulation Device May Stop Delivering Therapy

    LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.

    Product
    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, le
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0532-2022·2022-02-09

    Vagus Nerve Stimulation Therapy Leads Recalled for Tubing Wall Defect

    LivaNova's PerenniaDURA vagus nerve stimulation leads may have insufficient silicone tubing thickness due to a manufacturing issue. This could result in unintended stimulation delivery or loss of therapy if the tubing is breached.

    Product
    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)
    Category
    Medical Device
    Distribution
    7 states
  • ModerateFDA (Devices)·Z-0535-2021·2020-12-16

    LivaNova Recalls VNS Therapy SENTIVA DUO Generators Due to Model Number Error

    LivaNova is recalling eight SENTIVA DUO VNS Therapy generators because they display the incorrect model number after a device reset.

    Product
    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.
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0462-2021·2020-11-25

    LivaNova VNS Therapy AspireSR Generator Recall for Serial Number Error

    LivaNova is recalling 134 VNS Therapy AspireSR Generators because an extra digit in the serial number makes them incompatible with specific therapy programmers.

    Product
    VNS Therapy¿ AspireSR¿ Generator
    Category
    Medical Device
    Distribution
    29 states
  • LowFDA (Devices)·Z-2642-2020·2020-07-29

    LivaNova Recalls Sterile Disposable Connectors Due to Incorrect Reducer Parts

    LivaNova USA is recalling 140 sterile disposable connectors because some packages contained incorrect 3/8x1/4 reducers instead of the specified 1/2x1/2 connectors.

    Product
    LivaNova USA Sterile Disposable Connector,1/2x1/2, 20 units per case
    Category
    Medical Device
    Distribution
    5 states
  • SevereFDA (Devices)·Z-2455-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:050526000/ 00803622123320
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2463-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova USA Inc. is recalling 150 units of Vein Irrigation Cannulas with blunt tips because internal tests identified potential breaches in the sterile barrier.

    Product
    Vein Irrigation Cannula with blunt tip. ASY BIC, STERILE 25/CS REF/ GTIN for Insert Label:BIC/ 00803622133091
    Category
    Medical Device
    Distribution
    44 states
  • SevereFDA (Devices)·Z-2451-2020·2020-07-08

    LivaNova Recalls Sterile Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 600 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 3/8 X 1/4 24 REF/ GTIN for Insert Label:050516000/ 00803622123276
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2464-2020·2020-07-08

    LivaNova Recalls Vein Irrigation Cannulas Due to Sterile Barrier Breach

    LivaNova is recalling 325 Vein Irrigation Cannulas because internal tests found potential breaches in the sterile barrier, which could compromise sterility.

    Product
    Vein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label: VIC/ 00803622133107
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2445-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 1/4 X 3/8 REDUCER W/LL 24. REF/ GTIN for Insert Label:050434000/ 00803622123207
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2457-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 240 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2444-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY 3/16 X 3/16 STR CONNW/LL24. REF/ GTIN for Insert Label:050432000 / 00803622123184
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2458-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 20 units of Sterile Standalone Connectors because internal tests identified potential breaches in the sterile barrier.

    Product
    1/4X3/16X3/16YCONN,STRL REF/ GTIN for Insert Label:EC2102S/ 00803622129278
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2447-2020·2020-07-08

    LivaNova Recalls Sterile Standalone Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile standalone connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:050504000/ 00803622123221
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2456-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 768 units of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050529000/ 00803622123351
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2454-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 744 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY Y CONN 1/4 X 1/4 X 1/4 24 REF/ GTIN for Insert Label:050524000/ 00803622123306
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2449-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 648 units of Sterile Disposable Connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert Label:050506000/ 00803622123238
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2450-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S/1/4 TO 3/16 RED 24 REF/ GTIN for Insert Label:050514000/00803622123269
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2453-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY CONN EQUAL 3/16 WYE 24 REF/ GTIN for Insert Label:050523000/ 00803622123290
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2452-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Potential Barrier Breach

    LivaNova USA Inc. is recalling 96 units of sterile disposable connectors because internal tests found the sterile barrier may be breached.

    Product
    Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert label:050518000/ 00803622123283
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2446-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of Sterile Disposable Connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY STR CONN 3/16 STRLE 24. REF/ GTIN for Insert Label:050503000/ 00803622123214
    Category
    Medical Device
    Distribution
    44 states
  • HighFDA (Devices)·Z-2448-2020·2020-07-08

    LivaNova Recalls Sterile Disposable Connectors Due to Barrier Breach

    LivaNova USA Inc. is recalling specific lots of sterile disposable connectors because internal tests found potential breaches in the sterile barrier.

    Product
    Sterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:050513000/ 00803622123252
    Category
    Medical Device
    Distribution
    44 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

LivaNova

UK business

Country
United Kingdom
Founded
2015

Official website

Source: Wikidata (Q21592516), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.