Events

Retiro De Equipo (Recall) de Boston Scientific Equalizer Balloon Catheter

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 Boston Scientific Corporation.

¿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
    53471
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0195-2010
  • Fecha de publicación del evento
    2009-11-13
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-17
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85577
  • 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
    Percutaneous catheter - Product Code DQY
  • Causa
    Boston scientific is initiating a recall removal of numerous batches/lots of equalizer occlusion balloon catheter because the sterile barrier in the packaging of the affected product may be compromised. the outer pouch seal may be breached. if a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
  • Acción
    An Urgent Medical Device Recall Removal letter dated 09/29/2009 was sent to affected facilities and addressed to Risk Manager / Field Action Contact, beginning 09/29/2009. The letter explained the issue and identified product. Customers were asked to identify affected product within their inventory, segregate it and immediately return it to Boston Scientific. Customers will receive replacements for all recalled product that is returned. Customers were also to fax back to Boston Scientific the Reply Verification Tracking Form. Questions regarding this Recall Removal are directed to the local Sales Representative.

Device

Boston Scientific Equalizer Balloon Catheter
  • Modelo / Serial
    Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide. US distribution includes: AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT. NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and Washington D.C. and Puerto Rico. Worldwide distribution includes: Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates.
  • Descripción del producto
    Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Legal Manufacturer Boston Scientific Cork Ltd., Business and Technology Park, Model Farm Rd, Cork, Ireland.
  • Manufacturer
    Boston Scientific Corporation

Manufacturer

Boston Scientific Corporation
  • Dirección del fabricante
    Boston Scientific Corporation, 1 Scimed Pl, Maple Grove MN 55311-1565
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    USFDA