Events

Retiro De Equipo (Recall) de Device Recall PTA Balloon Dilatation Catheters

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 Bard Peripheral Vascular 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
    65395
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1533-2013
  • Fecha de inicio del evento
    2013-05-28
  • Fecha de publicación del evento
    2013-06-12
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2013-10-23
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118770
  • 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, percutaneous - Product Code DQY
  • Causa
    Bard peripheral vascular (bpv) has confirmed that some product code/lot number combination of devices may have the incorrect balloon diameter labeled on the inflation hub. specifically, the balloon size printed on the hub may read 7mm x 4cm, when the actual balloon size is 8mm x 4cm. all other product labeling is consistent with the actual 8mm x 4cm balloon size.
  • Acción
    BARD sent an URGENT MEDICAL DEVICE RECALL NOTIFICATION letters dated May 30, 2013 via FedEx overnight with proof of delivery notice to all affected customers. The letter identified the affected product, reason for recall, actions to be taken, and contact information. Customers were instructed to complete the enclosed Recall and Effectivenss Check Form and fax to the attention of Recall Coordinator in Customer Service at 1-800-994-6772.

Device

Device Recall PTA Balloon Dilatation Catheters
  • Modelo / Serial
    Product Codes and Lot Numbers, respectively:  VA8084R, 93JW0056 VA8084, 937W0090
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide Distribution
  • Descripción del producto
    BARD PERIPHERAL VASCULAR VACCESS¿ PTA Balloon Dilatation Catheters, 8mm x 4cm x 80cm. || Product Usage: Vaccess¿ PTA Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also recommended for post-dilatation of balloon expandable stents, self-expanding stents and stent grafts in the peripheral vasculature. This catheter is not for use in coronary arteries. Vaccess¿ PTA Balloon Dilatation Catheters are supplied sterile and intended for single use.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Dirección del fabricante
    Bard Peripheral Vascular Inc, 1625 W 3rd St Ste 109, Tempe AZ 85281-2438
  • Empresa matriz del fabricante (2017)
    Becton, Dickinson and Company
  • Source
    USFDA