Class 2 Device Recall Micrus Endovascular Microcoil Delivery System;

• Date Initiated by Firm: October 21, 2010
• Date Posted: January 03, 2011
• Recall Status: Terminated on January 11, 2011
• Recall Number: Z-0845-2011
• Recall Event ID: 57192
• 510(K)Number: K062036 K072173 K083646
• Product Classification: Device, neurovascular embolization - Product Code HCG
• Product: Micrus Endovascular Microcoil Delivery System;; The Micrus¿ Microcoil Delivery System consists of three components, a Microcoil System, a Connecting Cable, and a Detachment Control Box (DCB). Each component is sold separately. ; ; Catalog Numbers: ; PC4180933, SSR181128, CPL100252, ; PC4181647, SSR181640, CPL100404, ; DFS100254, SSR181230, CPL100406, ; DFS100410, DPL100206, SRC141230, ; CRC140304, DFS100716, CRC140406, ; CPL100203, DFS100204, DPL100408, ; SSR100253, PC4181240, DPL100202, ; CDF100408, PC4181137, CSP100500, ; CDF100154, PC4180830, CSP100350, ; DFS100152, SRC140408, PC4181034, ; CPL100206, CDF100152, SRC141025, ; SRC140225, CPL100304, CRC141025, ; CPL 100254, PC4181447, DPL100252, ; DFS100154, SRC140303, DFS100720, ; DPL 100204, PC4181343, CSP180500, ; DFS1 0031 0, DPL100306, DPL100256, ; CPL100306, CDF100304, CDF100203, ; CDF100410, PC4100412, DPL 100254, ; DPL 100053, PC41 00626, CDF100208, ; CRC140306, PC4100517, DFS100203, ; CSP181400, CPL 100152, DFS100210, ; CDF100720, CPL100204, CSP180200, ; DFS100204, CDF100510, DFS101025, ; DFS100408, PC41 00730, SSR181740, ; CRC140615, CPL100256, CDF100206, ; DFS100308, CPL100151, CSP100200, ; ; CDF100616, CRC140711, SSR181334, ; CDF100310, SRC140445, DFS100252, ; CPL100408, CDF100306, DFS100250, ; DPL 100152, DPL 100201, CDF100258, ; SRC140306, CDF100156, DPL 100153, ; DPL100304, SRC140922, SSR100825, ; DFS100206, DPL 100203, PC4181550, ; DFS100616, CSP180900, PC4181950, ; DFS100406, SRC140717, PC4181750, ; DFS100925, CSP100400, PC4181846, ; SRC140711, CPL100153, PC4182050, ; DFS100306, SRC140406, CSP100900, ; SRC140615, CDF100308, CSP100300, ; DFS1 0051 0, CDF100406, CDF1 0021 0, ; DFS100156, CDF100515, ; DPL100151, CDF100925, ; SSR181028, CDF101025, ; SSR181540, CPL 100201, ; SSR180825, CPL 100202; ; ; Manufactured and distributed by Micrus Endovascular Corporation, San Jose, CA
• Code Information: Lot Numbers: F62328 ,G11073 ,G11135 ,G11205 ,G11271 ,G11368 ,F62370 ,G11074 ,G11138 ,G11208 ,G11273 ,G11370 ,G10831 ,G11075 ,G11139 ,G11209 ,G11274 ,G11371 ,G10874 ,G11076 ,G11140 ,G11210 ,G11275 ,G11374 ,G10889 ,G11079 ,G11144 ,G11211 ,G11276 ,G11376 ,G10915 ,G11081 ,G11146 ,G11212 ,G11279 ,G11379 ,G10928 ,G11082 ,G11147 ,G11213 ,G11280 ,G11381 ,G10939 ,G11084 ,G11149 ,G11214 ,G11281 ,G11385 ,G10940 ,G11086 ,G11151 ,G11216 ,G11283 ,G11386 ,G10949 ,G11087 ,G11152 ,G11217 ,G11284 ,G11567 ,G10951 ,G11088 ,G11153 ,G11218 ,G11285 ,G11604 ,G10953 ,G11090 ,G11154 ,G11219 ,G11287 ,G11698 ,G10962 ,G11093 ,G11155 ,G11223 ,G11289 ,G11741 ,G10965 ,G11094 ,G11157 ,G11224 ,G11293 J10184 ,G10967 ,G11095 ,G11165 ,G11225 ,G11294 J10185 ,G10969 ,G11098 ,G11166 ,G11228 ,G11295 J10186 ,G10971 ,G11100 ,G11171 ,G11229 ,G11297 J10187 ,G10987 ,G11101 ,G11172 ,G11230 ,G11298 J10188 ,G10995 ,G11102 ,G11173 ,G11233 ,G11303 J10189 ,G10996 ,G11106 ,G11175 ,G11235 ,G11304 J10190 ,G10997 ,G11109 ,G11176 ,G11238 ,G11307 J10191 ,G11007 ,G11111 ,G11177 ,G11239 ,G11310 J10192 ,G11009 ,G11112 ,G11180 ,G11242 ,G11314 J10193 ,G11010 ,G11114 ,G11182 ,G11244 ,G11315 J10194 ,G11025 ,G11115 ,G11184 ,G11246 ,G11316 J10195 ,G11027 ,G11117 ,G11185 ,G11249 ,G11318 J10196 ,G11032 ,G11118 ,G11186 ,G11251 ,G11325 J10219 ,G11034 ,G11121 ,G11187 ,G11253 ,G11326 ,G10946 ,G11044 ,G11122 ,G11191 ,G11256 ,G11327 ,G11062 ,G11050 ,G11126 ,G11192 ,G11258 ,G11328 ,G11369 ,G11053 ,G11127 ,G11193 ,G11262 ,G11332 ,G11054 ,G11128 ,G11194 ,G11263 ,G11333 ,G11055 ,G11129 ,G11195 ,G11265 ,G11335 ,G11065 ,G11131 ,G11198 ,G11268 ,G11350 ,G11068 ,G11132 ,G11199 ,G11269 ,G11356 ,G11071 ,G11133 ,G11200 ,G11270 ,G11364
• Recalling Firm/ Manufacturer: Micrus Endovascular Corp., 821 Fox Lane, San Jose, CA 95131 ; 821 Fox Ln; San Jose CA 95131-1601
• For Additional Information Contact: Fritz Ender; 408-433-1400
• Manufacturer Reason for Recall: The firm has received reports of difficulty connecting to the detachment control cable. Loss of the electrical connection will result in failure to detach the coil for deployment inside an aneurysm.
• FDA Determined Cause: Other
• Action: Micrus Endovascular Corp sent Urgent: Medical Device Recall Letters dated October 21, 2010, to all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine inventory (including consignment) and quarantine the product to prevent it from being used or shipped. If the product was further distributed, customers were to notify their customers by sending a copy of the recall letter and were instructed to work with all customers to ensure that all product was returned and that pre-use protocol was followed. The response form was to be completed and returned indicating the number of devices that had been used (or shipped if distributor) and the number that would be returned. Customers were to call the Micrus Customer Service Department at 1-888-550-4129 from 8:00 am to 5:00 Pacific time for arrange for a Return Authorization number and replacement. Recall letters also stressed the importance of always following the pre-use protocol and inspecting the device immediately prior to use. Additionally, connector functionality should be verified and instructions were provided. Questions or concerns should be directed to Micrus Customer Service at 1-888-4120. Consignees who did not respond to the initial recall notification after 15 days were notified again by letter. A third letter was sent after another 15 days if there was still no response.
• Quantity in Commerce: 6755
• Distribution: Worldwide Distribution - USA including AK, AL, AZ, CA, CO, DC, DE, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV and the countries of Australia, Austria, Belgium, Canada, Chile, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Italy, Japan, Netherlands, Poland, Republic of Korea, Russia, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, and the United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = HCG and Original Applicant = MICRUS ENDOVASCULAR CORPORATION