Medtronic Archer 0.035 inch recall
Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage…
Why was Medtronic Archer 0.035 inch recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide. Product Usage…
- Recalling firm
- Medtronic Inc. Cardiac Rhythm Disease Management
- Quantity
- 27,682 devices
- Distribution
- 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.
- Recall date
- April 3, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)