SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away

Summary

The FDA issued a Class II for SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporaril by Boston Scientific Corporation. Reason: Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructi.

Details

Product Description

SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer to reduce the radiation dose delivered to the anterior rectum.

Lot/Code Info: UPN SO-1010, GTIN 00864661000157, Batch Numbers: 25512955, 25512956, 25608548, 25646105, 25652246, 25676663, 25676664, 25681783, 25814685, 25814686, 25814687, 25822800, 25822812, 25822814, 25822815, 25822818, 25846481, 26059500, 26199152, 26199153, 26199154, 26199155, 26223961, 26223962, 26223963, 26223964, 26223965, 26249663, 26296567, 26296568, 26330692, 26330693, 26330694, 26330695, 26360535, 26360536, 26392679, 26450673, 26450674, 26450675, 26479093, 26514195, 26514196, 26514197, 26514198, 26552142, 26552143, 26552144, 26552145, 26552146, 26552147, 26552148, 26552149, 26552150, 26559675, 26582245, 26582246, 26582247, 26582248, 26604083, 26604084, 26604085, 26620165, 26620166, 26747082, 26747083, 26747084, 26810389, 26810390, 26840623, 26840624, 26891606, 26891607, 26942179, 26943300, 26962856, 26962857, 27092550, 27092551, 27092552, 27123363, 27164903, 27164904, 27208217, 27224418, 27251110, 27251111, 27290123, 27290124, 27290125, 27290126, 27705892, 27705893, 27777685, 27777686, 27818531, 27818831, 27860308, 28189378, 28221394, 28221395, 28221396, 28221397, 28398571, 28398572, 28413030, 28535614; UPN SO-2101, GTIN 00864661000102, Batch Numbers: 25447885, 25449325, 25454386, 25454387, 25461459, 25495940, 25498279, 25498740, 25498741, 25498742, 25503112, 25503113, 25503114, 25503115, 25503116, 25506791, 25513909, 25513910, 25513911, 25513912, 25516002, 25516004, 25518766, 25518767, 25518769, 25518770, 25604214, 25604215, 25608549, 25630371, 25630372, 25630373, 25633109, 25638880, 25638881, 25638882, 25638883, 25640316, 25640317, 25646106, 25650375, 25650376, 25652248, 25652249, 25652250, 25660251, 25660252, 25661506, 25665261, 25665262, 25665263, 25681784, 25686490, 25686491, 25692043, 25698959, 25699200, 25699201, 25699202, 25706244, 25706245, 25707436, 25707437, 25712686, 25712687, 25712688, 25712689, 25720694, 25720695, 25720696, 25725090, 25743052, 25743053, 25743054, 25746319, 25746420, 25746421, 25746422, 25746423, 25748984, 25748985, 25748986, 25748987, 25752521, 25752522, 25752523, 25752524, 25773305, 25773306, 25775424, 25775425, 25780322, 25780323, 25829631, 25829632, 25829633, 25829634, 25829635, 25838013, 25838014, 25846482, 25846483, 25846484, 25846485, 25852659, 25852880, 25852881, 25852882, 25852883, 25861746, 25861747, 25876396, 25876397, 25876398, 25876399, 25876840, 25876841, 25878667, 25878668, 25878669, 25883155, 25883156, 25883157, 25883158, 25883159, 25889579, 25890040, 25890041, 25890042, 25891035, 25907181, 25907182, 25909720, 25909721, 25909722, 25909723, 25916278, 25916279, 25916440, 25916441, 25916442, 25916443, 25921966, 25921967, 25921968, 25921969, 25921970, 25934785, 25934786, 25934787, 25934788, 25934789, 25945186, 25945187, 25945188, 25945189, 25952097, 25952098, 25952099, 25963297, 25963298, 25963299, 25963440, 25970532, 25970533, 25988372, 25988373, 25988374, 25988375, 25997188, 26005315, 26005316, 26005317, 26005318, 26014544, 26014545, 26014546, 26028461, 26028462, 26028463, 26028464, 26028465, 26035128, 26035129, 26042542, 26042543, 26042544, 26042545, 26042546, 26042547, 26042548, 26058237, 26058238, 26058239, 26059080, 26059081, 26059501, 26060392, 26071663, 26071664, 26071671, 26071672, 26071673, 26071674, 26075962, 26075997, 26078689, 26078690, 26078691, 26078692, 26078693, 26088832, 26088833, 26088834, 26088835, 26088836, 26106496, 26106497, 26106498, 26106499, 26107243, 26107244, 26107245, 26107246, 26107247, 26111500, 26111501, 26111502, 26111503, 26111504, 26111505, 26121817, 26121818, 26121819, 26122100, 26128620, 26128621, 26128622, 26128623, 26137216, 26137217, 26170536, 26170537, 26172513, 26172514, 26172515, 26172516, 26172517, 26177019, 26177460, 26177461, 26178897, 26178898, 26184397, 26184398, 26184399, 26184580, 26184581, 26186561, 26186562, 26186563, 26186564, 26186565, 26187164, 26187165, 26191446, 26191447, 26191448, 26191449, 26191450, 26193736, 26193737, 26193738, 26209535, 26209536, 26209537, 26209538, 26212441, 26212442, 26212443, 26212444, 26216386, 26216387, 26216388, 26216389, 26216390, 26219745, 26219746, 26223179, 26223960, 26240334, 26240335, 26240336, 26240337, 26248777, 26248778, 26248779, 26248900, 26249466, 26249467, 26255000, 26255001, 26255002, 26255003, 26255004, 26257955, 26257956, 26257957, 26257958, 26264347, 26264348, 26264349, 26264350, 26264351, 26264352, 26268603, 26276556, 26276558, 26276559, 26287765, 26287766, 26287767, 26294565, 26301543, 26301544, 26301545, 26301546, 26302983, 26302984, 26308362, 26308363, 26308364, 26308365, 26308366, 26309943, 26316226, 26316227, 26316228, 26316229, 26325606, 26325607, 26360529, 26360530, 26360531, 26360532, 26390962, 26390963, 26390964, 26390965, 26390966, 26390967, 26479092, 26514199, 26514580, 26588906, 26588907, 26588908, 26588909, 26604086, 26604087, 26620161, 26620162, 26634757, 26634758, 26660269, 26736692, 26736693, 26736694, 26736695, 26736696, 26736697, 26747085, 26747086, 26754536, 26754537, 26774348, 26774349, 26774350, 26774351, 26774352, 26779764, 26780807, 26780808, 26780809, 26780810, 26789109, 26789110, 26789111, 26789112, 26789113, 26789114, 26793656, 26793657, 26812137, 26812138, 26812300, 26812301, 26812302, 26818264, 26818265, 26818266, 26818267, 26818268, 26825865, 26825866, 26825867, 26825868, 26825869, 26825875, 26826806, 26826807, 26826808, 26826809, 26839287, 26839288, 26839289, 26839290, 26841748, 26841749, 26841750, 26853559, 26853660, 26853661, 26853662, 26858288, 26858289, 26861588, 26861589, 26861590, 26861591, 26872638, 26872639, 26872940, 26872941, 26874784, 26880773, 26880774, 26893006, 26899183, 26899814, 26899815, 26906499, 26906601, 26908502, 26915827, 26915828, 26915829, 26915830, 26915831, 26929703, 26929704, 26929705, 26929706, 26929707, 26929708, 26943301, 26943302, 26943303, 26943304, 26946030, 26946031, 26946032, 26946033, 26946034, 26953304, 26953305, 26953306, 26953307, 26953308, 26962858, 26962859, 26975142, 26975143, 26975144, 26975145, 26975146, 26975147, 26977990, 26977991, 26977992, 26977993, 26984734, 26984735, 26984736, 26984737, 26984738, 27000738, 27000739, 27000920, 27000921, 27000922, 27010828, 27010829, 27012856, 27012857, 27024883, 27024884, 27024885, 27043543, 27043544, 27043545, 27043546, 27043547, 27054423, 27054424, 27054425, 27054426, 27054427, 27066782, 27066783, 27066784, 27066785, 27066786, 27068993, 27068994, 27068995, 27068996, 27068997, 27078868, 27078869, 27078870, 27078871, 27084715, 27084716, 27084717, 27084718, 27084719, 27092553, 27092554, 27092555, 27092556, 27100761, 27100762, 27100763, 27100764, 27100765, 27100766, 27107933, 27111856, 27208218, 27208219, 27221063, 27221064, 27231498, 27236459, 27236700, 27242448, 27242449, 27244886, 27244887, 27246025, 27246026, 27246027, 27251112, 27251113, 27252178, 27252179, 27257779, 27257800, 27260683, 27271944, 27271945, 27292531, 27292532, 27292533, 27292534, 27292535, 27413642, 27413643, 27413644, 27413645, 27413646, 27449092, 27449093, 27449095, 27449098, 27449100, 27449101, 27455961, 27455962, 27455963, 27455964, 27455965, 27469814, 27479346, 27479347, 27479348, 27479349, 27486742, 27486743, 27486745, 27505530, 27505531, 27505532, 27505533, 27599094, 27599096, 27602402, 27602404, 27602405, 27603120, 27652822, 27652823, 27652824, 27652825, 27655873, 27662657, 27662658, 27662659, 27663280, 27663281, 27679874, 27679876, 27679877, 27679879, 27743988, 27763343, 27763344, 27763345, 27763346, 27763347, 27763348, 27769335, 27769336, 27769337, 27793813, 27793814, 27793815, 27793816, 27806839, 27807080, 27807081, 27807082, 27807083, 27813807, 27813808, 27813809, 27819827, 27819828, 27848798, 27848799, 27849260, 27852324, 27852325, 27852326, 27860309, 27860310, 27863293, 27863294, 27868625, 27889555, 27889556, 27889557, 27889558, 27921327, 27921328, 27921329, 27921330, 27921441, 27941125, 27941126, 28030987, 28030988, 28030989, 28030990, 28030991, 28030992, 28030993, 28033235, 28033236, 28033237, 28033536, 28034352, 28034353, 28034354, 28034355, 28039068, 28039069, 28039070, 28039071, 28053880, 28053881, 28053882, 28060816, 28060817, 28062669, 28062670, 28062671, 28068730, 28068731, 28075079, 28075500, 28083772, 28083773, 28104421, 28110690, 28110691, 28110692, 28116632, 28116633, 28116639, 28116920, 28138215, 28138216, 28138217, 28138218, 28144107, 28144108, 28150892, 28150893, 28163398, 28163820, 28163821, 28163822, 28179664, 28179665, 28187744, 28187745, 28187746, 28187747, 28187748, 28187749, 28196188, 28196189, 28201559, 28237148, 28237149, 28237150, 28237151, 28237390, 28237391, 28237392, 28294715, 28294716, 28294717, 28306763, 28311109, 28311110, 28313987, 28313988, 28313989, 28323411, 28323412, 28323413, 28335610, 28335611, 28335612, 28350362, 28350363, 28350364, 28350365, 28358408, 28358409, 28389631, 28389632, 28389633, 28389634, 28398573, 28398574, 28398575, 28419101, 28432890, 28432891, 28446435, 28446436, 28446437, 28463387, 28463388, 28464793, 28499509, 28499510, 28499511, 28499512, 28536808, 28536809, 28549083, 28549084, 28549085, 28558906, 28558907, 28558908, 28565354, 28600712, 28600713, 28600714, 28600715, 28600716, 28600717, 28600718, 28608550, 28608551, 28608552, 28613671, 28613672, 28613673, 28613674, 28623413, 28623414, 28623415, 28661032, 28661033, 28661034, 28694688, 28694689, 28707783, 28707784, 28734765, 28734766, 28734767, 28734768, 28743894, 28766549, 28766550, 28766551, 28778877, 28778878, 28778879; UPN SO-3101, GTIN 00864661000164, Batch Numbers: 25985439, 26140617, 26140618, 26140619, 26141060, 26141061, 26141062, 26170538, 26249662, 26517605, 28377015; UPN SO-4101, GTIN 00864661000126, Batch Numbers: 25449321, 25450979, 25454390, 25731415, 25731416, 25731579, 25732220, 25765632, 25765633, 25765634, 25814682, 25814683, 25838015, 25838016, 25838017, 25838018, 25852884, 25980707, 25980708, 25980709, 25980710, 25980711, 26021050, 26021051, 26021052, 26021053, 26060390, 26060391, 26071456, 26071458, 26111508, 26111509, 26111510, 26111511, 26170539, 26199156, 26248901, 26248902, 26257959, 26258400, 26287768, 26287769, 26294566, 26294567, 26334369, 26334370, 26360533, 26360534, 26436689, 26436690, 26436691, 26436692, 26436693, 26436694, 26436695, 26436696, 26479094, 26559676, 26559677, 26559678, 26559679, 26565454, 26565455, 26565456, 26588911, 26588912, 26604088, 26604089, 26620163, 26620164, 26627125, 26627126, 26627127, 26627128, 26641185, 26641186, 26641188, 26644531, 26644714, 26751685, 26751686, 26751687, 26751688, 26751689, 27197339, 27197621, 27207235, 27231495, 27231496, 27231497, 27253522, 27258004, 27258005, 27268188, 27274046, 27274047, 27274048, 27274049, 27296389, 27296390, 27296391, 27358080, 27358081, 27360957, 27360958, 27360959, 27731084, 27731085, 27731086, 27743989, 27743990, 27777687, 27777688, 27818832, 27818833, 27854598, 27854599, 27854820, 27880084, 27880085, 28051253, 28059295, 28059296, 28062672, 28068732, 28074277, 28083774, 28103327, 28103328, 28103329, 28134238, 28134239, 28135200, 28135201, 28135202, 28135203, 28189379, 28189380, 28196192, 28202161, 28377016, 28377017, 28398576, 28398577, 28406228, 28514992, 28514993, 28535613, 28578840, 28656267, 28656268, 28656269, 28656270, 28708930, 28743895, 28743896, 28788166, 28788167, 28788172

Quantity Affected: 61,852 units

Reason for Recall

Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that describe steps to verify correct placement of the hydrogel following implantation, as well as technique recommendations for the proper placement of SpaceOAR and SpaceOAR Vue.

Type: Voluntary: Firm initiated

Recall Initiated: 2022-02-24

Company