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 number

Z-0977-2009

Recalling firm

Boston Scientific Corporation

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.

Status

Terminated

Initiated

2008-12-24

Posted

2009-02-13

Terminated

2010-05-11

Reason

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.

Root 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

83,435

Distribution

Worldwide Distribution.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

KNS

Firm FEI

1051710

Firm city

Miami

Firm state

FL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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