LivaNova USA Inc.: 13 recalls on record

Recalls filed with 1 agency: FDA (13).

First recall on record: August 8, 2018. Most recent: February 12, 2025.

Risk classification: Class II: 13

Most recent recalls

DateAgencyProduct
February 12, 2025FDASenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulatio…Z-1073-2025
February 9, 2022FDAVagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 303-20 Per…Z-0532-2022
November 25, 2020FDAVNS Therapy¿ AspireSR¿ GeneratorZ-0462-2021
July 8, 2020FDASterile Disposable Connectors ASY RDC Y 1/2X3/8X3/8 STR 24 REF/ GTIN for Insert Label:050…Z-2456-2020
July 8, 2020FDAVein Irrigation Cannula with blunt tip. ASY VIC, STERILE 25/CS REF/ GTIN for Insert Label…Z-2464-2020
July 8, 2020FDASterile Disposable Connectors ASY STR CONN 1/4 STRLE 24. REF/ GTIN for Insert Label:05050…Z-2447-2020
July 8, 2020FDASterile Disposable Connectors ASY Y CONN 3/8 X 3/8 X 3/8 24 REF/ GTIN for Insert Label:05…Z-2455-2020
July 8, 2020FDASterile Disposable Connectors ASY S CONN 3/16X1/8 RDR ANLD24 REF/ GTIN for Insert Label:0…Z-2448-2020
July 8, 2020FDASterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:05060…Z-2457-2020
March 25, 2020FDALivaNova Heater-Cooler System 3T - Product Usage: The Heater-Cooler 3T System is used to …Z-1498-2020
December 18, 2019FDAVNS Therapy Program GMDN: 44077 Model # 3000 V1.5.2, RxOnlyZ-0663-2020
November 13, 2019FDAThe LivaNova VNS Therapy System, used for Vagus Nerve Stimulation (VNS), consists of an i…Z-0346-2020
August 8, 2018FDAVNS Therapy Programming System, Rx Only, Model 3000, v1.0.2.2Z-2572-2018

Questions about this company

How many recalls does LivaNova USA Inc. have?
Recalert has 13 U.S. recalls on record for LivaNova USA Inc., published between August 8, 2018 and February 12, 2025.
What was the most recent LivaNova USA Inc. recall?
FDA recall Z-1073-2025, published February 12, 2025: SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst Stimulation. Used for Vagus Nerve Stimulation (VNS).
Which agencies have handled LivaNova USA Inc. recalls?
LivaNova USA Inc. appears as the recalling firm in recalls from: FDA (13).

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