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SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and… recallZ-1002-2022 · Boston Scientific Corporation · initiated Feb 24, 2022

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Boston Scientific Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Labeling design

What the company is doing

An URGENT MEDICAL DEVICE PRODUCT ADVISORY dated 2/24/22 was sent to customers. Inadvertent placement of SpaceOAR gel into a blood vessel and subsequent migration of the hydrogel outside of the pelvis, led to embolism. Boston Scientific will incorporate best practices regarding hydrogel placement during all SpaceOAR procedures into the IFU. The updated IFUs will be packaged with SpaceOAR and SpaceOAR Vue Systems after regulatory approvals are obtained for the IFU updates. This Product Advisory contains the recommended IFU updates, located in Appendix 1, intended to: -Raise awareness of embolism as an existing adverse event. -Add new Warnings and Precautions that describe technique recommendations for the placement of SpaceOAR and SpaceOAR Vue to reduce the unintentional placement of hydrogel. - Add procedural instructions to reduce the unintentional placement of hydrogel in a blood vessel and steps to verify placement of the hydrogel following implantation. NO product is being recalled and you are NOT required to return product to Boston Scientific. As per the IFU, SpaceOAR and SpaceOAR Vue System procedures should only be performed by physicians who have received appropriate training for proper hydrogel spacer deployment technique. The Acknowledgement Form must be completed and returned even if you do not have any affected units. Return the Acknowledgement Form by Email: [email protected] or Fax to: Field Action Center 1-763-415-7708

Recall details

Recall number
Z-1002-2022
Status
Open, Classified
Initiated by the company
Feb 24, 2022
Recalling firm
Boston Scientific Corporation
Quantity
61,852 units
Product code
OVB
FDA submissions
K181465, K202224
Distribution
Worldwide - US Nationwide distribution.

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.

Code information (models, lots, serial numbers)

Show the full code information (11k characters)

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 89862).

Sources and updates

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