Archer 0.035 inch (0.89mm) Super Stiff Guidewire


  • Empresa matriz del fabricante (2017)
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
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  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire
  • Manufacturer
  • Modelo / Serial
    Model ARCSJ200W Lot Numbers: GFWC1124, GFWC1506, GFWC2138, GFWC2652, GFWC2653, GFWD0353, GFWD0881, GFWD0882, GFWD2048, GFWD2049, GFWD2050, GFWD2051, GFWD2052, GFWE0743, GFWE0744, GFWE0745, GFWE0746, GFWE0747, GFWE3710, GFWE4272, GFWE4273, GFWE4274, GFWE4275, GFWF0143, GFWF0144, GFWF0147, GFWF0148, GFWF0149, GFWG0428, GFWG0429, GFWG0430, GFWG0431, GFWG0432, GFWG0433, GFWG0434, GFWH0333, GFWH0334, GFWH0335, GFWH0336, GFWH0337, GFWH0338, GFWI0190, GFWI0191, GFWI0192, GFWI0193, GFWI0194, GFWI0195, GFWJ0027, GFWJ0028, GFWJ0029, GFWJ2454, GFWJ2455, GFWJ2456, GFWJ2457, GFWJ2458, GFWK1910, GFWK1911, GFWL0370, GFWL2571, GFWL2572, GFXA0224.   Model ARCSJ260W Lot Numbers: GFWC1501, GFWC1502, GFWC1503, GFWD0883, GFWD0884, GFWD3256, GFWE0752, GFWE0753, GFWE3711, GFWF0145, GFWF0150, GFWG0425, GFWG0426, GFWG0427, GFWH0344, GFWH0345, GFWI0201, GFWI0202, GFWI0203, GFWJ0418, GFWJ0419, GFWJ0420, GFWJ2461, GFWJ2462, GFWJ2464, GFWJ2465, GFWL0368, GFWL0369, GFWL0415, GFWL0416, GFXA0219, GFXA0220, GFXA0221, GFXA0222.   Model ARCDJ260W Lot Numbers: GFWC1507, GFWC1508, GFWD0885, GFWE0750, GFWE0751, GFWF0142, GFWF0146, GFWG0423, GFWG0424, GFWH0331, GFWH0332, GFWI0186, GFWI0187, GFWI0188, GFWJ2449, GFWJ2450, GFWJ2451, GFWJ2452, GFWK1844.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide Distribution - USA (nationwide) including Puerto Rico and the countries of: Argentina, Armenia, Australia, Austria, Belgium, Bolivia, Canada, Chile, China, Colombia, Croatia, Czech Republic, Ecuador, El Salvador, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Israel, Italy, Jordan, Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Montenegro, Morocco, Netherlands, New Zealand, Norway, Oman, Philippines, Poland, Portugal, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela, Viet Nam.
  • Descripción del producto
    Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. || Product Usage: || The Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
  • Manufacturer