Retiro De Equipo (Recall) de Device Recall MICROSHEATH 0.066 (1.7mm) proximal, 0.064 (1.6mm);

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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    Marker, radiographic, implantable - Product Code DQY
  • Causa
    Bard peripheral vascular (bpv) is initiating this recall because a combination of bard¿ ultraclip¿ dual trigger tissue marker's and support catheters (microsheath and usher) were inadvertently distributed to customers without completing the sterilization process (non sterile).
  • Acción
    The firm, BARD Peripheral Vascular, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter on January 23, 2013, to its customers. Bard EXPANDED its recall to include (MicroSheath and Usher support Catheters) and sent another "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated March 5, 2013 describing the additional products, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed as follows: Do not use or further distribute any affected product; check all inventory locations within your institution; remove any identified product from your shelves and return to Bard Peripheral Vascular, Inc. 1415 W. 3rd Street, Tempe, AZ 85281; if you have further distributed any of the product, immediately contact that location and advise them of the recall and have them return to BPV; If you have used the affected product, consider notifying, educating and monitoring those affected; and complete and return the Recall and Effectiveness Check form via fax to: ATTN; Recall Coordinator in Customer Service at 1-800-994-6772, even if you no longer have possession of the product; if unable to FAX call BPV at 1-800-321-4254 Option #2 Ex 2727 and report verbally. Please call our Recall Coordinator at 1-800-321-4254 Option #2 Ext 2727 (M-F 7am to 4pm MST) or email at with any questions.


  • Modelo / Serial
    PC MS17123; Lot# FCWC10010
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Nationwide Distribution including AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, IL, IN, KY, KS, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, PA, TX, VA, WA, WV and WY.
  • Descripción del producto
    MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide; minimum ID: 0.086"/ (2.2mm);distal, straight non-tapered tip; PK1018-03A; Bard Peripheral Vascular; Manuf: Flow Cardia, Inc., a Subsidiary of C.R. Bard, Inc. 745 North Pastoria Ave., Sunnyvale, CA 94085. || The MicroSheath and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. MicroSheath¿ is a single lumen catheter that has a 123cm working length and a straight tip shape
  • Manufacturer


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