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.

Reason: Medtronic has identified an issue involving specific lot numbers of the Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W, where a change in the manufacturing process has been identified as the cause for potential kinking and breaking at the proximal weld end of the outer spring coil during in-vivo use.

Code information: 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.

Distribution pattern: 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.