Device Recall Innova SelfExpanding Stent System

a. 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);  b. Innova 5 x 200 x 75 (Batch No. 18343796, 18115802, 18379813, 19013283, 21124110);  c. 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);  d. Innova 6 x 200 x 75 (Batch No. 18389661, 18623249, 18870949, 18900366, 19161485, 19245285, 19918786, 20635844, 20862432, 21098043);  e. 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);  f. Innova 7 x 200 x 75 (Batch No. 18336507, 18598712, 18733075, 18802238, 18892409, 18999955, 19151414, 19245286, 19511477, 19569668, 19684652, 19811430, 20699739, 20729796, 20978808, 21122996);  g. 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);  h. Innova 8 x 200 x 75 (Batch No. 18115809, 18313157, 18877978, 19161490, 19624794, 19887625, 20410535, 20862411)

Cardiovascular Devices

3

Yes

Worldwide Distribution - US Nationwide Distributed domestically to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV. Distributed internationally to Canada

Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows: || Product Usage: || The Innova Vascular Self-Expanding Stent System is indicated to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) with reference vessel diameters from 4.0 mm to 7.0 mm and lesion lengths up to 190 mm. || a. H74939293052030 (Material Description Innova 5 x 200 x 130); || b. H74939293052070 (Material Description Innova 5 x 200 x 75); || c. H74939293062030 (Material Description Innova 6 x 200 x 130); || d. H74939293062070 (Material Description Innova 6 x 200 x 75); || e. H74939293072030 (Material Description Innova 7 x 200 x 130); || f. H74939293072070 (Material Description Innova 7 x 200 x 75); || g. H74939293082030 (Material Description Innova 8 x 200 x 130); || h. H74939293082070 (Material Description Innova 8 x 200 x 75)

Lot: 14186932, 14212643, 14212648, 14222479.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.

Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05127. 5 mm x 120 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. || The Innova Self-Expanding Stent is available in a variety of diameters and lengths. || The delivery system is also offered in two working lengths (75 cm and 130 cm). || The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

Lots: 14185609, 14186566.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.

Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05157. 5 mm x 150 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. || The Innova Self-Expanding Stent is available in a variety of diameters and lengths. || The delivery system is also offered in two working lengths (75 cm and 130 cm). || The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

Lot: 14188380.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.

Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05187. 5 mm x 180 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. || The Innova Self-Expanding Stent is available in a variety of diameters and lengths. || The delivery system is also offered in two working lengths (75 cm and 130 cm). || The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

Lot: 14190185.

Cardiovascular Devices

3

Yes

Worldwide Distribution - USA (nationwide) and the countries of Product removal in US is being managed through SuperNOVA Clinical Trial suspension in accordance with IDE #G100291. OUS distribution to include: Austria, Finland, France, Germany, Italy, Netherlands, Spain, and Switzerland.

Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05207. 5 mm x 200 mm x 75 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. || The Innova Self-Expanding Stent is available in a variety of diameters and lengths. || The delivery system is also offered in two working lengths (75 cm and 130 cm). || The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions