openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 6
SMART FLEX 9x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
Code information
Product Code: SF09060SB; Lot No. 253349
Distribution pattern
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
device · product 2 of 6
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
Code information
Product Code: SF06120MB; Lot No. 266401
Distribution pattern
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
device · product 3 of 6
SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
Code information
Product Code: SF06150MB; Lot No. 266415, 266417, and 266419
Distribution pattern
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
device · product 4 of 6
SMART FLEX 8x60 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
Code information
Product Code: SF08060SB; Lot No. 266523
Distribution pattern
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
device · product 5 of 6
SMART FLEX 10x100 BIL, 80cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
There is a potential for distal tip dislodgement or separation.
Code information
Product Code: SF10100SB; Lot No. 266586
Distribution pattern
US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.
device · product 6 of 6
SMART FLEX 10x100 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
