Boston Scientific Corporation: Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

Recall number

Z-0608-2007

Recalling firm

Boston Scientific Corporation

Product

Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500

Status

Terminated

Initiated

2006-12-20

Posted

2007-03-13

Terminated

2007-12-12

Reason

Guidewire restriction during use (excessive adhesive in the guidewire lumen)

Root cause

Other

Action

On December 20, 2006, Boston Scientific notified all US consignees by letter sent via Fed Ex Priority mail. Customers are instructed to remove affected product from inventory and return it to Boston Scientific. The notification also requested the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product in inventory. Boston Scientific International Regulatory Affairs was notified and is responsible the monitoring foreign recall.

Quantity

8,511 for Recalls Z-0604-0609-2007

Distribution

Worldwide distribution --- USA and countries of Austria, Belgium, France, Czech Republic, Germany, great Britain, Greece,Ireland, Italy, Luxemburg, Netherlands, Norway, Poland, Portugal, Spain, Switzerland, and Sweden.

Lot, serial or model codes

Lot Numbers: 7889255, 7892445, 7905372, 7905374, 7920200, 7920201, 7920402, 7924984, 7928220, 7928221, 7940540, 7940541, 7944156, 7944157, 7948736, 7959298, 7967031, 7967032, 7974510, 7974511, 7979467, 7987625, 7987626, 7987628, 7991050, 7996574, 7996575, 8002683, 8014023, 8014024, 8037243, 8037244, 8037245, 8037246, 8041303, 8041304, 8052776, 8056276, 8056277, 8071724, 8071725, 8075136, 8075137, 8090847, 8090848, 8090849, 8093631, 8097643, 80097646, 8111219, 8117677, 8129796, 8129797, 8135040, 8150710, 8150711, 8166095, 8166096, 8170748, 8170749, 8187006, 8187007, 8191491, 8191492, 8195575, 8206782, 8211777, 8221857, 8221858, 8226825, 8226826, 8251328, 8268292, 8284683, 8286814, 8286815, 8286816, 8290951, 8290953, 8303330, 8303331, 8306943, 8322847, 8322848, 8326864, 8338442, 8346569, 8346570, 8359761, 8359762, 8359863, 8364161, 8364162, 8381248, 8381249, 8381250, 8401049, 8401050, 8410838, 8410839, 8410840, 8423298, 8423299, 8431393, 8442256, 8442257, 8446291, 8446292, 8449737, 8463164, 8463246, 8470264, 8470590, 8470592, 8482831, 8482832, 8490451, 8502347, 8502348, 8502609, 8502727, 8502728, 8502869, 8502973, 8502974, 8502975, 8502976, 8502977, 8502978, 8502979, 8502980, 8502981, 8502982, 8503290, 8503291, 8503292, 8503293, 8503294, 8503295, 8503296, 8503297, 8507018, 8507019, 8511086, 8511087, 8521622, 8526130, 8541944, 8541945, 8551221, 8563750, 8563751, 8563752, 8567702, 8567703, 8588514, 8588516, 8591865, 8591866, 8603141, 8603142, 8620591, 8620592, 8624527, 8624528, 8645198, 8645199, 8645203, 8652468, 8652469, 8655870, 8662303, 8662304, 8662305, 8666752, 8666753, 8666754, 8671097, 8683742, 8683743, 8692107, 8692108, 8705449, 8705846, 8714060, 8714427, 8714428, 8732163, 8732165, 8736497, 8748514, 8748520, 8748521, 8752576, 8752577, 8771059, 8775285, 8789042, 8789044, 8793117, 8793118, 8819197, 8819198, 8831249, 8833912, 8833913, 8834149, 8867179, 8867180, 8871566, 8889077, 8889079, 8889080, 8893395, 8893396, 8898056, 8898057, 8913684, 8913687, 8917868, 8917869, 8931675, 8931676, 8931677, 8947925, 8968803, 8968804, 8968805, 8972725, 8972726, 9132193, 9132194, 9132195, 9132196, 9132197, 9132198, 9132199, 9132200, 9132201, 9132206, 9132207, 9132208, 9132209, 9132210, 9132211, 9132292, 9132293, 9132294, 9132295

510(k) numbers

["K964119"]

PMA numbers

not on file

Product code

FGE

Firm FEI

3001451463

Firm city

Natick

Firm state

MA

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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