Home / Recalls / LivaNova USA Inc. / Z-2457-2020

Z-2457-2020 Class II Terminated

Recalled by LivaNova USA Inc. — Arvada, CO

Recall Details

Product Type
Devices
Report Date
July 8, 2020
Initiation Date
April 24, 2020
Termination Date
February 17, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
240 units

Product Description

Sterile Disposable Connectors ASY 1/2 CONN W/LL STRLE 24 REF/ GTIN for Insert Label:050608000/ 00803622123382

Reason for Recall

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 associated to a specific production period.

Distribution Pattern

US - AK, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WV OUS- Spain (Hospital de Barsuto, Bilbao, Spain)

Code Information

LOT 2003400088

Other recalls by LivaNova USA Inc.

  • Z-1068-2025 Class II — Brand Name: SenTiva DUO" Product Name: VNS Therapy¿ SenTiva DUO", Model 1000-D (January 3, 2025)
  • Z-1067-2025 Class II — Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva", Model 1000 Model/Cat (January 3, 2025)
  • Z-1072-2025 Class II — SenTiva, REF: 1000; SenTiva Duo, REF: 1000-D; Generators Part of the VNS Therapy (December 12, 2024)
  • Z-1073-2025 Class II — SenTiva, REF: 1000C, Generators Part of the VNS Therapy System with Microburst S (December 12, 2024)
  • Z-0532-2022 Class II — Vagus Nerve Stimulation (VNS) Therapy Leads, PerenniaDURA, Model: 303. Model 3 (December 2, 2021)
  • Z-0535-2021 Class II — VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of (November 12, 2020)
  • Z-0462-2021 Class II — VNS Therapy¿ AspireSR¿ Generator (September 28, 2020)
  • Z-2443-2020 Class II — Sterile Disposable Connectors ASY CONN Y 1/2X1/2X3/8 STR 24. REF/ GTIN for Inser (April 24, 2020)
  • Z-2449-2020 Class II — Sterile Disposable Connectors ASY ASY STR CONN 3/8 STRLE 24 REF/ GTIN for Insert (April 24, 2020)
  • Z-2452-2020 Class II — Sterile Disposable Connectors ASY CONN REDUCER 1/2 X 3/8 24 REF/ GTIN for Insert (April 24, 2020)