Events

Retiro De Equipo (Recall) de Device Recall ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Cardiovascular Systems Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    76928
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1877-2017
  • Fecha de inicio del evento
    2017-02-09
  • Fecha de publicación del evento
    2017-04-10
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2017-07-27
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154580
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Catheter, peripheral, atherectomy - Product Code MCW
  • Causa
    Csi is recalling three lots of viperwire advance with flextip peripheral atherectomy guidewire . it was discovered that 0.018in viperwire advance with flextip product was packaged as a 0.014in viperwire advance with flextip.
  • Acción
    On 2/9/2017, consignees were sent a CSI "Urgent Medical Device Recall" letter dated 09 February 2017. The letter described the Affected Product, Recall Description, & Instructions. Advised consignees to immediately remove, return the product & complete the Customer Acknowledgement Form. For further information contact Customer Service, Cardiovascular Systems, Inc., 1225 Old Highway 8 NW Saint Paul, MN 55112 877-274-0901 - Tel, 612-677-3355 - Fax.

Device

Device Recall ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire
  • Modelo / Serial
    Lot #: 175069, 175070, 176255
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NJ, NY, OH, OR, PA, SC, SD, TN, TX, and WA
  • Descripción del producto
    ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14. || Product Usage: || The Stealth 360 Orbital PAD System and the Diamondback 360 Peripheral Orbital Atherectomy System are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The OAS is a percutaneous orbital atherectomy system indicated as a therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty.
  • Manufacturer
    Cardiovascular Systems Inc

Manufacturer

Cardiovascular Systems Inc
  • Dirección del fabricante
    Cardiovascular Systems Inc, 1225 Old Highway 8 NW, Saint Paul MN 55112-6416
  • Empresa matriz del fabricante (2017)
    Cardiovascular Systems, Inc.
  • Source
    USFDA