Boston Scientific Corporation 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. Recall
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According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Boston Scientific Corporation
Lot Codes / Batch Numbers
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.
Products Sold
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.
Boston Scientific Corporation is recalling Gold Probe 7FR Working Length: 300 cm, Probe Tip O.D. 2.3 mm (7Fr), Rx Only. Electrical Connector: due to 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 Gol. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026