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Boston Scientific Corporation Recall 89862

Description: SpaceOAR Vue System, UPN SV-1010 and SV-2101. 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.

Boston Scientific Corporation Recall 89862 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1003-2022
Event ID89862
Event DescriptionSpaceOAR Vue System, UPN SV-1010 and SV-2101. 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 TypeDevices
DistributionWorldwide - US Nationwide distribution.
Quantity23,368 units
Recall ReasonUsers 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.
Device Classification20220504
Device Code InfoUPN SV-1010, GTIN 00850009803009, Batch Numbers: 26383209, 26383210, 26517604, 26861584, 26861585, 26891612, 26891613, 27083784, 27190242, 27210560, 27257801, 27257802, 27455966, 27455967, 27496959, 27497140, 27670956, 27708041, 27708042, 27708043, 27930863, 27930864, 27941129, 27941130, 27949315, 28094077, 28247077, 28247078, 28358778, 28377018, 28377019, 28464794, 28464795, 28496461, 28496462, 28578758, 28578759, 28608231, 28608232; UPN SV-2101, GTIN 00864661000140, Batch Numbers: 26345481, 26376961, 26376962, 26376963, 26376964, 26380456, 26380457, 26384055, 26384056, 26408849, 26485974, 26485975, 26485977, 26486586, 26486587, 26486588, 26493461, 26517606, 26517607, 26529719, 26567283, 26567284, 26567285, 26567286, 26567287, 26574373, 26574374, 26574378, 26574379, 26574441, 26611593, 26611594, 26611595, 26652286, 26652287, 26691824, 26691826, 26691827, 26691828, 26705563, 26705564, 26705565, 26705566, 26728564, 26728565, 26743769, 26743770, 26743771, 26743772, 26745057, 26770161, 26770162, 26770163, 26770164, 26770165, 26861586, 26880769, 26880770, 26880771, 26880772, 26898042, 26898043, 26898044, 26898045, 26899812, 26899813, 26906603, 26906604, 26929712, 26929713, 26929714, 26929715, 26929716, 26929717, 26929719, 26929860, 26929861, 26957514, 26957515, 26957516, 26957517, 26969537, 26969538, 26969539, 26970440, 26970441, 26970442, 27010832, 27040235, 27040236, 27060422, 27060423, 27060424, 27060425, 27060426, 27078872, 27078873, 27084457, 27084458, 27084459, 27084960, 27100768, 27100769, 27100770, 27123402, 27123404, 27140485, 27140486, 27163487, 27163488, 27180605, 27190243, 27190244, 27190245, 27190686, 27193837, 27193838, 27193839, 27194460, 27194461, 27197622, 27197623, 27214381, 27214382, 27214383, 27224419, 27257804, 27257805, 27259062, 27259063, 27259064, 27259065, 27268186, 27268187, 27283462, 27283463, 27283464, 27283465, 27283466, 27317224, 27317225, 27317226, 27329273, 27329274, 27329275, 27358004, 27358005, 27361380, 27361381, 27382203, 27382204, 27416003, 27416004, 27416005, 27416006, 27416007, 27444898, 27444899, 27445360, 27447905, 27469811, 27469812, 27469813, 27475230, 27496957, 27496958, 27512052, 27512053, 27512054, 27512055, 27517685, 27518868, 27518869, 27528492, 27531152, 27531153, 27531154, 27531155, 27531156, 27531157, 27601494, 27601495, 27657444, 27657445, 27657446, 27670942, 27670945, 27670946, 27670949, 27705891, 27720117, 27720118, 27720119, 27745215, 27745216, 27756475, 27769338, 27769339, 27769860, 27769861, 27769862, 27769863, 27797083, 27797084, 27797085, 27797086, 27797087, 28094078, 28094079, 28094320, 28103330, 28104177, 28104178, 28104179, 28104420, 28110684, 28110685, 28110686, 28110687, 28116634, 28116635, 28138219, 28138440, 28146630, 28146631, 28169753, 28169754, 28169755, 28179669, 28179670, 28179671, 28202160, 28237387, 28237388, 28237389, 28247079, 28247160, 28247161, 28247162, 28247269, 28247270, 28247271, 28247272, 28254386, 28254387, 28254388, 28265943, 28265944, 28265945, 28265946, 28265947, 28272556, 28272557, 28272558, 28272559, 28272560, 28287355, 28287356, 28294718, 28294719, 28311111, 28311112, 28323414, 28323415, 28323416, 28323417, 28335613, 28335614, 28350366, 28350367, 28350368, 28350369, 28364006, 28364007, 28364008, 28371227, 28371228, 28371229, 28389635, 28389636, 28412353, 28419102, 28419103, 28432892, 28432893, 28473289, 28473290, 28493777, 28493778, 28499505, 28499506, 28499507, 28555843, 28565355, 28565356, 28565357, 28587389, 28587390, 28587391, 28587392, 28587393, 28587394, 28605867, 28606252, 28611099, 28612440, 28612441, 28612442, 28613189, 28635760, 28635761, 28635762, 28635763, 28654059, 28654440, 28654441, 28663263, 28663264, 28663265, 28668946, 28668947, 28668948, 28683114, 28683115, 28686271, 28686272, 28686273, 28694687, 28707785, 28709642, 28709643, 28714572, 28723144, 28734763, 28734764, 28758266, 28766992, 28766993, 28766994, 28766995, 28766996, 28811555, 28811556, 28811558, 28811560, 28819972, 28819973, 28821692, 28821693, 28822526, 28822527, 28828281, 28828282, 28836638, 28836639, 28838125
Center Classification Date20220425
Recall Initiation Date20220224
Recalling FirmBoston Scientific Corporation
Initial Notification Letter
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