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U.S. Department of Health and Human Services

Class 2 Device Recall Superion IDS Kit

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 Class 2 Device Recall Superion IDS Kitsee related information
Date Initiated by FirmJune 06, 2025
Date PostedSeptember 02, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2485-2025
Recall Event ID 97109
PMA NumberP140004 
Product Classification Prosthesis, spinous process spacer/plate - Product Code NQO
ProductSuperion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 The Superion IDS Kit includes a set of proprietary instruments to deliver the Superion Implant in a minimally invasive manner. Instruments specifically designed for implanting the Superion Implant are sterile, single-use disposable instruments, consisting of a Dilator Assembly, Cannula Assembly, Interspinous Gauge, Inserter, Reamer, and Driver.
Code Information Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 ALL Lot/Batch Number: 40280174 40145632 40117221 40113198 40113255 40113385 40113391 40113482 40106856 40027385 26176977 800276 800301 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 ALL Lot/Batch Numbers: 40222297 40213592 40199967 40198809 40195249 40186649 40181505 40166300 40157622 40141657 40141770 40136859 40131798 40132036 40112806 40106870 40093564 40080016 40080111 40076497 40070306 40070307 40052009 40045101 40034339 40027338 40027364 40022398 40018296 40018338 40010128 40004038 40004068 40000647 30244690 30178729 29985230 29849515 29849969 29668712 29668713 29578948 29578949 29360265 29360263 29360264 29160559 29160625 28756501 28627193 28627192 28627194 28501592 28501591 28501593 28344375 28344376 28344377 28133122 800279 800345 800269 800278 800268 800280 800261 800270 700089 800259 800260 800258 800250 800317 800318 700085 Superion Indirect Decompression System 12MM, VF Implant 101-9812 00884662000543 ALL Lot/Batch Numbers: 40280071 40245960 40222355 40211234 40211404 40211463 40199117 40199211 40186760 40165937 40157506 40157279 40139759 40140041 40132011 40129328 40114193 40114290 40106757 40106924 40093299 40093565 40080015 40080124 40070323 40051777 40045673 40045706 40044635 40045080 40027314 40027337 40027346 40018297 40018311 40018344 40018360 40010112 40010126 40010144 40004051 40004081 40003228 40000665 30244396 30244397 29985232 29985233 29927752 29850082 29850085 29850083 29788495 29667699 29668637 29668640 29623992 29556093 29547992 29540069 29540067 29540068 29394426 29360815 29361201 29361220 29361221 29361159 29361200 29243822 29244010 29244067 29244068 29170416 29164935 28737193 28627392 28627985 28627195 28620905 28545960 28460945 28460942 28460944 28460941 28460943 28444915 28344378 28344379 28282295 28282296 28133124 28133125 28133123 28123077 28051836 28047778 28047777 28047779 27909032 27844690 27812316 27812317 27809085 27809084 27783073 27783072 27787123 27771035 27735759 27707788 27696311 27657263 27657244 27641430 27619527 27620200 27593135 27594003 27576476 27576376 27558963 27553036 27535575 27531204 27508978 27509115 27509116 26929604 26929605 26928168 26815560 26815561 26807662 26654632 26573432 26489700 26375758 800340 800349 800297 800303 800339 800273 800272 800282 800283 800284 800285 700090 700091 800265 800271 800274 800295 800298 700087 700088 800263 800264 700086 800262 700084 Superion Indirect Decompression System 14MM, VF Implant 101-9814 00884662000550 ALL Lot/Batch Numbers: 40222018 40222380 40211257 40186588 40165998 40113412 40113503 40113583 40113602 40113620 40113621 40113640 40106796 40093429 40051972 40045632 40045657 40027363 40018299 40018362 40000650 29262518 30244395 30244806 29985231 29850095 29703521 29547991 29539391 29523354 29393128 29393129 29394425 29170296 29164945 29164946 28756502 28693439 28628060 28627199 28501594 28501595 28336412 28144010 27868456 27735900 27707785 27707787 27535576 26848047 26799951 26619510 26406210 26366842 26323984 800342 800300 800341 800266 800287 800286 800304 800275 800299 Superion Indirect Decompression System 16MM, VF Implant 101-9816 00884662000567 ALL Lot/Batch Numbers: 40293569 40198619 40186436 40080053 40070342 40051973 40018345 29703520 29575558 27783071 27535578 800267 800343 800277 Superion Indirect Decompression System Kit, VF Instrument 102-9800 00884662000574 ALL Lot/Batch Numbers: 40277815 40277874 40277890 40277911 40278004 40278100 40278101 40276344 40276407 40276430 40276444 40276525 40276527 40276566 40276587 40276605 40276646 40276663 40276664 40271124 40262838 40262970 40263108 40257898 40258441 40258462 40257952 40258003 40258047 40258067 40258102 40258140 40258141 40256318 40256554 40256555 40256590 40256627 40256645 40256684 40256706 40254134 40254135 40254153 40254211 40254212 40254256 40254257 40254258 40254259 40254274 40254335 40254349 40254350 40254398 40254464 40254465 40254466 40254467 40254521 40254522 40254542 40245657 40240497 40240498 40240793 40240878 40240888 40240931 40240970 40240971 40240972 40241044 40241068 40241105 40241144 40241145 40235666 40233094 40232369 40232387 40232388 40232405 40232429 40232472 40232489 40232495 40232591 40232595 40232653 40232657 40225393 40224452 40223799 40223952 40223953 40223955 40223976 40223995 40223996 40224033 40224035 40224075 40224148 40224151 40224163 40224221 40224222 40224240 40224241 40213780 40207876 40207916 40207958 40208033 40208115 40208135 40208176 40208179 40208192 40208193 40208206 40208242 40208260 40208261 40203693 40200036 40200037 40200038 40200375 40200409 40200489 40200490 40200491 40200541 40200581 40200582 40194379 40188515 40188549 40188550 40188606 40188666 40188745 40188762 40188780 40188781 40181371 40170319 40170702 40167812 40167813 40167838 40167879 40167935 40167958 40167991 40168037 40168049 40168071 40168072 40168110 40168134 40168135 40168152 40168160 40168210 40168211 40168235 40168274 40168276 40168277 40168288 40168304 40168344 40168345 40168362 40168380 40160900 40154501 40154155 40154177 40154197 40154350 40154463 40154520 40154117 40154178 40154191 40154278 40154314 40154323 40154483 40154190 40154249 40154384 40149401 40149057 40149073 40149170 40149189 40149207 40149240 40149285 40149420 40148893 40149032 40149230 40149286 40149331 40148858 40149011 40149113 40149114 40149241 40145762 40145822 40143655 40143716 40143752 40143855 40143871 40143909 40143924 40143946 40143947 40143985 40144020 40134946 40133855 40133897 40133911 40133936 40133937 40133952 40133967 40134027 40134053 40134101 40134102 40134103 40133293 40133296 40133358 40133397 40133447 40133463 40133468 40133469 40133470 40133531 40133532 40133565 40133585 40133642 40133661 40133682 40131356 40131605 40130713 40130814 40130827 40130828 40130871 40130872 40130931 40130949 40130950 40130962 40131001 40131021 40131040 40131041 40131060 40130339 40130608 40130625 40130686 40130724 40129893 40129936 40129951 40129952 40130048 40130049 40130084 40129331 40125198 40125233 40125234 40125279 40125336 40125337 40125371 40125405 40125406 40125422 40125442 40125460 40103890 40103929 40103942 40103965 40097538 40097594 40095880 40093337 40093547 40080113 40080126 40070305 40070324 40061940 40061941 40061942 40049517 40049518 40049532 40049533 40049546 40049582 40049583 40049620 40045674 40045707 40045102 40029126 40027366 40027367 40027380 40018346 40018347 40018348 40018363 40018380 40010115 40010145 40010146 40004039 40000646 40000664 30244392 30244683 30244393 30176679 30176800 29985417 29985418 29985653 29985654 29985656 29985416 29927753 29850126 29850127 29850125 29850124 29788497 29668584 29668719 29668718 29668586 29668589 29668583 29623991 29584313 29584314 29584563 29584564 29584565 29583233 29412417 29412419 29412416 29412418 29413200 29394389 29243962 29210479 29194952 29194950 29160621 29160623 29160624 29041369 28992639 28864332 28756504 28756506 28756505 28756503 28731511 28696720 28696722 28696721 28696723 28696724 28696725 28694129 28544317 28545962 28544318 28545001 28544319 28545000 28545002 28436250 28436249 28436251 28426894 28385093 28336246 28192765 28192766 28192767 28137208 28051837 27939716 27939715 27939717 27844930 27695955 27085645 27007948 26960437 26799950 26768008 26654631 26632676 26489612 26406212 26406211 26375759 26374481 26366778 26341632 26323985 26284114 26284118 26267257 26177045 26177047 26177046 204066 204105 204103 204094 204085 204083 204052 204044 204032 204025 204019 The Vertiflex Procedure Instrument Platform, VF Instrument 140-9800 00884662000611 ALL Lot/Batch Numbers: 40285562 40278696 40278718 40278719 40278759 40278775 40278776 40278831 40278858 40278889 40278926 40279000 40279020 40270458 40270474 40270726 40270727 40270840 40262795 40262839 40262993 40262994 40262995 40262996 40263009 40263048 40263049 40263086 40263131 40263132 40263143 40263144 40263181 40263200 40259198 40259253 40259254 40259315 40259334 40259378 40259419 40259507 40259546 40259564 40259565 40259584 40259601 40258239 40258249 40258295 40258318 40258372 40258391 40258444 40258463 40258481 40241339 40241413 40241458 40241538 40241539 40241550 40241552 40241595 40241650 40241743 40241744 40241762 40241780 40232352 40232370 40232371 40232457 40232474 40232475 40232496 40232511 40232609 40232610 40232611 40232612 40232613 40232635 40232636 40232672 40232700 40224914 40224357 40224372 40224418 40224419 40224453 40224533 40224534 40224569 40224610 40224628 40224645 40224680 40209996 40209998 40210110 40210129 40210261 40210262 40210280 40210281 40209105 40209188 40209291 40209312 40209346 40209347 40209480 40209481 40204291 40204292 40204314 40204525 40204547 40203639 40203739 40203793 40203794 40203838 40203839 40203875 40203945 40203963 40203981 40203982 40204001 40204002 40204021 40204040 40204061 40204080 40189518 40189519 40189617 40189618 40189619 40189656 40189727 40189728 40189729 40189730 40189731 40189747 40189849 40189906 40189940 40189941 40171416 40171417 40171475 40171497 40171516 40171549 40171619 40171708 40171762 40171782 40170898 40170919 40170995 40171088 40171107 40171108 40171163 40171220 40171240 40171241 40171242 40171243 40155518 40155694 40155805 40155880 40155539 40155751 40155825 40155864 40155881 40155598 40155619 40155637 40155647 40155675 40155729 40155750 40155804 40155597 40155693 40155803 40150438 40150619 40150881 40150771 40150784 40150901 40150675 40150727 40150749 40150785 40150882 40150883 40150674 40150696 40150710 40150770 40150783 40150803 40150862 40150880 40150900 40150902 40150709 40150802 40149817 40149796 40149950 40149994 40150031 40150032 40150103 40128791 40128851 40128852 40128931 40128993 40129007 40129008 40129009 40129032 40129063 40129111 40129150 40127593 40127612 40127653 40127685 40127707 40127731 40127771 40127787 40127800 40127827 40127842 40127880 40127900 40127920 40127135 40127197 40127207 40127211 40127231 40126331 40106731 40106946 40093528 40093529 40080127 40070341 40061839 40061876 40061960 40049519 40049547 40049570 40049584 40049603 40049604 40045675 40045692 40029087 40027318 40027347 40018314 40018351 40018381 40018382 40010095 40010113 40000587 40000633 40000634 30244684 30244686 30244685 29985748 29985749 29985750 29985752 29985755 29985758 29850008 29850009 29850007 29850006 29668654 29668699 29668594 29668595 29668593 29668698 29584137 29584560 29584561 29584139 29584562 29584138 29448373 29448375 29448374 29448372 29448371 29211740 29211744 29211743 29211742 29211741 29211745 28993461 28993460 28792503 28792504 28792505 28731513 28649637 28650340 28649639 28649635 28649638 28649636 28501596 28501597 28501598 28385086 28385084 28301015 28301016 28301014 28226777 28226776 28226778 27968504 27968505 27968506 27121980 27120119 26897475 26887527 26727980 26574211 26451355 26416847 26366800 26361434 26361887 26323986 26284115 26284119 26177049 26177744 26176372 26177038 26177050 26178139 26178704 26169429 26170979 204106 204067 204104 204095 204086 204084 204053 204045 204033 204026 204020
Recalling Firm/
Manufacturer		 Boston Scientific Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia CA 91355-5004
For Additional Information ContactRenee Archie
508-683-4523
Manufacturer Reason
for Recall		As a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
FDA Determined
Cause 2		Device Design
ActionOn 06/06/2025, the firm sent an "Urgent Medical Device Removal - Immediate Action Required" Letter to customers inform them that, as a result of a comprehensive performance review of the Superion system and have determined that it is not meeting expected performance levels during the implantation procedure which includes breakage of the instrument (e.g., driver tip and insertion tool) and the device (e.g., spindle cap). Customer are instructed to: Physicians should stop all implants of the Superion Indirect Decompression System. Further distribution or use of any remaining affected product should cease immediately. This recall notification does not apply to Superion devices that have already been implanted and they can continue to remain in use. Boston Scientific is not recommending explant of successfully implanted Superion devices. 1. Continue to report all device-related incidents or quality concerns experienced with the Superion Indirect Decompression System to Boston Scientific. 2. Please segregate all Superion Indirect Decompression System product immediately and return it to Boston Scientific in accordance with the enclosed instructions. Complete and return the RVTF to get a Return Goods Authorization (RGA) number. "Indicate the quantity of SINGLE units you will be returning for credit "If you have product that is listed in Attachment 1 (Affected Products) that is not included on your RVTF, provide the material number, lot number, and quantity you intend to return on your RVTF "Return the RVTF via: Email: BSCFieldActionCenter@bsci.com, or Fax: BSC Field Action Center 1-763-415-7708 Public Contact - Renee Archie 508-683-4523 or email Renee.Archie@bsci.com
Quantity in Commerce70,516
DistributionU.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
PMA DatabasePMAs with Product Code = NQO
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