Reported Feb 28, 2018 · Ongoing

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows

Boston Scientific Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 2 Scimed Pl · Maple Grove, MN · 55311-1565

Is this the product you have?

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows

8 of 8 products

Products covered by this recall
#	Product as published
1	H74939293052030 (Material Description Innova 5 x 200 x 130)
2	H74939293052070 (Material Description Innova 5 x 200 x 75)
3	H74939293062030 (Material Description Innova 6 x 200 x 130)
4	H74939293062070 (Material Description Innova 6 x 200 x 75)
5	H74939293072030 (Material Description Innova 7 x 200 x 130)
6	H74939293072070 (Material Description Innova 7 x 200 x 75)
7	H74939293082030 (Material Description Innova 8 x 200 x 130)
8	H74939293082070 (Material Description Innova 8 x 200 x 75)

Lot codes and dates: 8 of 8 products
Products covered by this recall
# Product as published
1 Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593)
2 Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110)
3 Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052)
4 Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043)
5 Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652)
6 Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996)
7 Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667)
8 Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)
Amount recalled: 22,916 units total

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description…

Where it was sold

Why it was recalled

Stent possibly unable to be fully released from the delivery system.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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135 in total.

Where it was distributed

All recall categories · Browse the whole archive

#	Product as published
1	Innova 5 x 200 x 130 (Batch No. 18095733, 18137885, 18233108, 18379812, 18362996, 18420576, 18404859, 18457350, 18478823, 18488703, 18519986, 18696468, 18670333, 18667082, 18756979, 18855752, 18844729, 18872178, 18886680, 18866631, 18892405, 18900294, 18951278, 19039704, 19064055, 19079251, 19111601, 19173251, 19206070, 19238815, 19231426, 19351863, 19309202, 19382422, 19367647, 19426956, 19483869, 19490837, 19501322, 19540549, 19540559, 19569664, 19641827, 19750808, 19742326, 19830060, 19844547, 19873365, 19907333, 19970577, 20014162, 20080095, 20096498, 20112175, 20186872, 20223208, 20216043, 20435880, 20151952, 20444934, 20439618, 20314154, 20336209, 20394072, 20608020, 20608137, 20607734, 20657170, 20420612, 20337854, 20450027, 20616298, 20777472, 20470018, 20672513, 20832034, 20876897, 20871401, 20728970, 20776633, 20851808, 20975844, 21020806, 21124105, 21045072, 21057925, 21091417, 21115593)
2	Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110)
3	Innova 6 x 200 x 130 (Batch No. 18152540, 18137923, 18096697, 18119044, 18119040, 18115810, 18230863, 18108301, 18230864, 18211280, 18211281, 18245462, 18230637, 18230636, 18410450, 18428643, 18473268, 18283383, 18343799, 18439907, 18431333, 18368130, 18523235, 18519980, 18661526, 18488709, 18389662, 18498563, 18515152, 18446693, 18733063, 18759192, 18759189, 18766678, 19540741, 18791863, 18832544, 18792872, 18855754, 18860236, 18823216, 18866636, 18844738, 18892194, 18900365, 18870948, 18872541, 18878446, 18900381, 18888435, 18988348, 18961203, 19064043, 18945808, 19072771, 19111551, 19079253, 19151922, 19116475, 19164618, 19206072, 19226126, 19141574, 19245284, 19240145, 19288826, 19288832, 19309205, 19309206, 19367648, 19377502, 19408962, 19426948, 19389007, 19490838, 19511466, 19501332, 19517646, 19545788, 19555598, 19560848, 19569663, 19589370, 19584757, 19641826, 19635253, 19664685, 19654162, 19670616, 19709446, 19728413, 19699320, 19782868, 19693686, 19682956, 19682955, 19830064, 19873362, 19907334, 19905446, 19941738, 19942503, 19918783, 20013959, 19970579, 20014164, 20023939, 20109861, 20188996, 20080098, 20080097, 20188052, 20187538, 20080096, 20109863, 20112179, 20320562, 20830984, 20216045, 20183756, 20158213, 20433364, 20434473, 20233669, 20286988, 20233670, 20303729, 20342627, 20233668, 20607288, 20574727, 20607402, 20455108, 20368051, 20432603, 20511193, 20394775, 20594724, 20635843, 20776979, 20478648, 20821884, 20754076, 20758252, 20821886, 20800469, 20886809, 20825353, 20885852, 20938124, 20913156, 20950528, 20975845, 20997424, 21004412, 21119055, 21117395, 21058225, 21098042, 21071017, 21122202, 21145025, 21145024, 21219047, 21219242, 21219052)
4	Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043)
5	Innova 7 x 200 x 130 (Batch No. 18152541, 18099223, 18130828, 18113523, 18230638, 18217571, 18211282, 18186723, 18240225, 18168041, 18291418, 18339045, 18368242, 18283384, 18339044, 18316737, 18394605, 18385509, 18420569, 18313150, 18488713, 18921110, 18961213, 19072776, 19134318, 19173258, 19161488, 19206078, 19228862, 19255680, 19288830, 19309211, 19377507, 19327253, 19408970, 19436702, 19483875, 19491821, 19501423, 19527344, 19555961, 19545789, 19624864, 19659433, 19693528, 19670619, 19709445, 19830069, 19811429, 19742336, 19918785, 19907336, 19851529, 19974524, 19974523, 20080094, 20001802, 20109860, 20001803, 20188364, 20109862, 20177945, 20181650, 20210393, 20244728, 20321275, 20320380, 20286989, 20434033, 20267930, 20405389, 20381126, 20316570, 20574731, 20607286, 20352590, 20442151, 20466869, 20622461, 20655052, 20495971, 20518171, 20628127, 20777268, 20777261, 20820730, 20731022, 20833824, 20758256, 20886953, 20819295, 20856506, 20910181, 20937554, 21004415, 21119514, 20997428, 21119515, 21045505, 21103020, 21058247, 21138682, 21217652)
6	Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996)
7	Innova 8 x 200 x 130 (Batch No. 18211294, 18313156, 18385119, 18519981, 18583365, 18611781, 18733076, 18754584, 18780335, 18844724, 18977671, 19006855, 19048092, 19072779, 19188060, 19245289, 19304348, 19351866, 19454525, 19501424, 19624788, 19664694, 19684647, 19839023, 19782933, 20014160, 20080099, 20112342, 20216047, 20286991, 20439603, 20386608, 20655679, 20655677, 20329707, 20410534, 20655798, 20357647, 20997431, 21123358, 21123667)
8	Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)