Events

Retiro De Equipo (Recall) de Boston Scientific, BackUp Meier Steerable Guidewires

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
    55620
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1760-2010
  • Fecha de inicio del evento
    2010-04-19
  • Fecha de publicación del evento
    2010-06-04
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-12-10
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91343
  • 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
    Wire, guide, catheter - Product Code DQX
  • Causa
    Boston scientific corporation is conducting a medical device recall of certain lots/batches of its back-up meier steerable guidewires. through their internal inspection process, they identified that the polytetrafluoroethylene (ptfe) coating on the gold plated distal coil of the back-up meier steerable guidewires of the identified lots/batches have the potential for ptfe delamination. inconsist.
  • Acción
    Consignees were sent a Boston Scientific "Urgent Medical Device Recall" letter dated April 19, 2010. The letter was addressed to Risk Manger/Field Action Contact. The letter described the problem and product affected and recommended that to immediately discontinue use of and segregate recalled product. They also requested the consignee to complete and return the Account Reply Verification Tracking Form. Customers with questions are directed to the firm's Field Action Coordinator at (763-) 494-1417.

Device

Boston Scientific, BackUp Meier Steerable Guidewires
  • Modelo / Serial
    Lot/Batch 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13188299 13188448 13188850 13189372 13191119 13191900 13214230 13215622 13217713 13218224 13218422 13218654 13230493 13231032 13231763 13235212 13237044 13237266 13237865 13244785 13245496 13250396 13250705 13250811 13255106 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13168826 13188292 13189005 13191912 13192123 13192691 13194328 13205603 13212484 13212647 13214988 13220752 13223805 13224584 13225209 13230183 13230872 13235343 13235437 13237414 13240493 13241294 13244517 13245964 13253646 13260267 13189367 13200586 13213574 13217494 13241577 13254666 13189367 13200586 13213574 13217494 13241577 13254666
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    AL, AZ, AR, CA, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MS, MO, NJ, NM, NY, NC, OH, OR, PA, SC, SD, TN TX, VT, VA, WA. SWITZERLAND, GERMANY, FINLAND, FRANCE, ITALY, JORDAN, POLAND, SWEDEN, CANADA. Complete consignee list not available at this time.
  • Descripción del producto
    Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. || The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a very flexible and shapeable distal tip. The tip area consists of a radio-opaque gold-plated tungsten spring coil wound around a stainless-steel inner core. The usable length of the guidewire is 185 cm, 260 cm and 300 cm. || Material (UPN) H965SCH306000; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm FLEX J TIP, Single / Single. || Material (UPN) H965SCH306001; Catalog # SCH-30600; Product Description / Number BACK-UP MEIER .035 in, 185cm, J TIP B5 /5 per Box. || Material (UPN) H965SCH306010; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX, FLEX C, Single/ Single. || Material (UPN) H965SCH306011; Catalog # SCH-30601; Product Description / Number BACK-UP MEIER .035 in, 300cm EX C TIP B5/5 per Box. || Material (UPN) M001306020; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP, SINGLE/Single. || Material (UPN) M001306021; Catalog # 30-602; Product Description / Number MEIER WIRE 260 cm .035 w/C TIP 5 PER BX/5 per Box.
  • 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