SpaceOAR Vue System recall
SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for…
Why was SpaceOAR Vue System 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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- SpaceOAR Vue System, UPN SV-1010 and SV-2101. Used to temporarily position the anterior rectal wall away from the prostate during radiotherapy for…
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 23,368 units
- Distribution
- Worldwide - US Nationwide distribution.
- Recall date
- May 4, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)