Class 2 Device Recall MICROVASIVE GOLD PROBE

• Date Initiated by Firm: December 24, 2008
• Date Posted: February 13, 2009
• Recall Status: Terminated on May 11, 2010
• Recall Number: Z-0977-2009
• Recall Event ID: 50697
• Product Classification: Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
• Product: Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: Standard. For Single Use Only. Legal Manufacturer, Boston Scientific Corporation, One Boston Scientific Place Natick, MA 01760-1537 USA. Made in USA: 8600 N.W. 41st Street Miami, FL 33166-6202 USA. The device is indicated for use in transendoscopic electrocautery of visible bleeding and nonbleeding sites in the gastrointestinal tract including the esophagus, stomach, duodenum, and colon.
• Code Information: Lot Numbers for UPN M00560070: 9237058, 9242307, 9246342, 9265070, 9268728, 9272427, 9298292, 9302175, 9320321, 9324018, 9335827, 9341572, 9359902, 9376203, 9386673, 9390027, 9406078, 9410110, 9420346, 9425527, 9437988, 9443899, 9447626, 9466351, 9470374, 9482071, 9486110, 9489319, 9513036, 9517669, 9525255, 9528819, 9539767, 9544065, 9547291, 9574443, 9578122, 9602462, 9602528, 9606498, 9620098, 9623071, 9623100, 9623197, 9623397, 9632534, 9663181, 9666486, 9684482, 9684484, 9684485, 9689670, 9703937, 9708837, 9734006, 9746669, 9749624, 9749625, 9749627, 9750734, 9760158, 9770675, 9772909, 9783444, 9791088, 9827743, 9830764, 11002747, 11014998, 11021760, 11032121, 11054202, 11061692, 11065332, 11068413, 11087476, 11092084, 11095657, 11117289, 11120886, 11125670, 11136295, 11150676, 11153938, 11157330, 11175379, 11183495, 11187100, 11190386, 11208628, 11211359, 11215867, 11225034, 11257463, 11261004, 11301624, 11315777, 11331624, 11333846, 11349839, 11352808, 11375194, 11378966, 11397734, 11400415, 11425859, 11430776, 11448194, 11451668, 11452871, 11455664, 11473931, 11478628, 11482202, 11502663, 11506259, 11514450, 11518314, 11536951, 11555850, 11560166, 11563841, 11581312, 11585150, 11588552, 11603391, 11607318, 11626199, 11629148, 11632317, 11650606, 11653698, 11658172, 11683821, 11684991, 11690159, 11693994, 11720081, 11723522, 11726262, 11754297, 11759875, 11771875, 11775495, 11790418, 11793861, 11807042, 11808883, 11812197, 11834416, 11840561, 11854505, 11858113, 11874533, 11878883, 11892028, 11895817, 11916396, 11919863, 11922245, 11934979, 11939632, 11954003, 11958207, 11965207, 11983076, 12001707, 12004909, 12022530 and 12033767. Lots Numbers for UPN M00560071: 9250053, 9253199, 9274922, 9279867, 9287088, 9290056, 9307665, 9312999, 9316758, 9348516, 9351987, 9363466, 9368267, 9382130, 9397996, 9401006, 9429622, 9431373, 9435008, 9455619, 9461328, 9493337, 9496154, 9508560, 9510052, 9531833, 9535769, 9552122, 9565745, 9570253, 9587492, 9589049, 9596109, 9599316, 9613556, 9617014, 9641022, 9673179, 9677504, 9684522, 9696760, 9698268, 9713213, 9718808, 9738217, 9743598, 9756826, 9793613, 9797075, 9813026, 9822793, 9826394, 11009246, 11012401, 11025542, 11028694, 11047245, 11049898, 11073503, 11077497, 11080455, 11099298, 11102577, 11107280, 11110742, 11139525, 11143357, 11161747, 11164974, 11180003, 11197392, 11201257, 11228360, 11238916, 11242523, 11245661, 11250295, 11253892, 11278679, 11284687, 11291615, 11295068, 11308482, 11312283, 11341473, 11343030, 11346396, 11363872, 11366629, 11381378, 11386944, 11409113, 11412987, 11416827, 11430777, 11437348, 11442171, 11467643, 11470657, 11485518, 11488894, 11492574, 11495885, 11509421, 11528339, 11533342, 11547440, 11552151, 11566569, 11570397, 11592124, 11610875, 11614199, 11635571, 11639554, 11643662, 11665274, 11669321, 11672022, 11676512, 11701498, 11704984, 11708130, 11734168, 11738370, 11745073, 11761484, 11764687, 11781627, 11783202, 11799806, 11803572, 11819967, 11824012, 11842065, 11844494, 11859922, 11863225, 11866437, 11883712, 11888148, 11903196, 11907510, 11910637, 11925318, 11928967, 11932560, 11947301, 11950696, 11967330, 11970893, 11986374, 11989126, 11994790, 12009780, 12016332, 12019093, 12044519, 12048303, 12055414 and 12058228.
• FEI Number: 1051710
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 8600 Nw 41st St; Miami FL 33166-6202
• For Additional Information Contact: 305-597-4273
• Manufacturer Reason for Recall: Packaging tray for the Gold Probe Single-Use BiPolar Electrohemostasis Catheters may have a crack. Cracks in the tray or damage to the tray of the Gold Probe device may lead to a compromised sterile barrier.
• FDA Determined Cause: Packaging process control
• Action: A notification letter (dated December 24, 2008) was issued to customers. The letter identified the issue. Consignees are instructed to: 1) Discontinue use and segregate affected product, 2) Complete a Reply Verification Tracking Form and fax to the Boston Scientific Corporation (BSC) at 508-683-5578 and 3) Package and ship recalled product as instructed in the letter. If affected product is found, customers are instructed to call BSC Customer Service at 1-866-868-4004 between 8:30 a.m. through 6:00 p.m. (Eastern Standard Time). Please direct questions about the recall to your local Sales Representative.
• Quantity in Commerce: 83,435
• Distribution: Worldwide Distribution.
• 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.