Boston Scientific Corporation: Medical Device Recall in 2022 - (Recall #: Z-1003-2022)

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.

Class II

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.

UPN 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

Worldwide - US Nationwide distribution.

Voluntary: Firm initiated