Z-1002-2022Class II

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

Name: Z-1002-2022 SpaceOAR System, UPN SO-1010, SO-2101, SO-3101, and SO-4101. Used to temporarily position the anterior rectal...
Creator: Boston Scientific Corporation
Published: 2022-02-24
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2022-02-24 / Open, Classified / root cause: labeling and UDI

FDA source

Boston Scientific Corporation began a recall of 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... on 2022-02-24. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1002-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-02-24
Posted: 2022-04-25
Recalling firm: Boston Scientific Corporation
Product: 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.
Product code: OVB Hydrogel Spacer
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: 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
Quantity in commerce: 61,852 units
Distribution: Worldwide - US Nationwide distribution.
Product codes and lots: 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, 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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, 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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, 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28398576, 28398577, 28406228, 28514992, 28514993, 28535613, 28578840, 28656267, 28656268, 28656269, 28656270, 28708930, 28743895, 28743896, 28788166, 28788167, 28788172

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1002-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1002-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-25
Z-1003-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-05-04	2022-04-25

Product code OVB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)