Home / Recalls / Medtronic Inc. Cardiac Rhythm Disease Management / Z-1019-2013

Z-1019-2013 Class II Terminated

Recalled by Medtronic Inc. Cardiac Rhythm Disease Management — Saint Paul, MN

Recall Details

Product Type
Devices
Report Date
April 3, 2013
Initiation Date
March 13, 2013
Termination Date
February 6, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
27,682 devices

Product Description

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 for Recall

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.

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.

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.

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