{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "214586", "product_res_number": "Z-2485-2025", "event_date_initiated": "2025-06-06", "event_date_posted": "2025-09-02", "recall_status": "Open, Classified", "res_event_number": "97109", "product_code": "NQO", "pma_numbers": [ "P140004" ], "product_description": "Superion IDS Kit\nSuperion Indirect Decompression System 8MM, VF Implant\n101-9808\n00884662000529\n\nSuperion Indirect Decompression System 10MM, VF Implant\n101-9810\n00884662000536\n\nSuperion Indirect Decompression System 12MM, VF Implant\n101-9812\n00884662000543\n\nSuperion Indirect Decompression System 14MM, VF Implant\n101-9814\n00884662000550\n\nSuperion Indirect Decompression System 16MM, VF Implant\n101-9816\n00884662000567\n\nSuperion Indirect Decompression System Kit, VF Instrument\n102-9800\n00884662000574\n\nThe Vertiflex Procedure Instrument Platform, VF Instrument\n140-9800\n00884662000611\n\n\nThe 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_info": "Superion Indirect Decompression System 8MM, VF Implant\n101-9808\n00884662000529\nALL Lot/Batch Number:\n40280174\n40145632\n40117221\n40113198\n40113255\n40113385\n40113391\n40113482\n40106856\n40027385\n26176977\n800276\n800301\n\nSuperion Indirect Decompression System 10MM, VF Implant\n101-9810\n00884662000536\nALL Lot/Batch Numbers:\n40222297\n40213592\n40199967\n40198809\n40195249\n40186649\n40181505\n40166300\n40157622\n40141657\n40141770\n40136859\n40131798\n40132036\n40112806\n40106870\n40093564\n40080016\n40080111\n40076497\n40070306\n40070307\n40052009\n40045101\n40034339\n40027338\n40027364\n40022398\n40018296\n40018338\n40010128\n40004038\n40004068\n40000647\n30244690\n30178729\n29985230\n29849515\n29849969\n29668712\n29668713\n29578948\n29578949\n29360265\n29360263\n29360264\n29160559\n29160625\n28756501\n28627193\n28627192\n28627194\n28501592\n28501591\n28501593\n28344375\n28344376\n28344377\n28133122\n800279\n800345\n800269\n800278\n800268\n800280\n800261\n800270\n700089\n800259\n800260\n800258\n800250\n800317\n800318\n700085\n\nSuperion Indirect Decompression System 12MM, VF Implant\n101-9812\n00884662000543\nALL Lot/Batch Numbers:\n40280071\n40245960\n40222355\n40211234\n40211404\n40211463\n40199117\n40199211\n40186760\n40165937\n40157506\n40157279\n40139759\n40140041\n40132011\n40129328\n40114193\n40114290\n40106757\n40106924\n40093299\n40093565\n40080015\n40080124\n40070323\n40051777\n40045673\n40045706\n40044635\n40045080\n40027314\n40027337\n40027346\n40018297\n40018311\n40018344\n40018360\n40010112\n40010126\n40010144\n40004051\n40004081\n40003228\n40000665\n30244396\n30244397\n29985232\n29985233\n29927752\n29850082\n29850085\n29850083\n29788495\n29667699\n29668637\n29668640\n29623992\n29556093\n29547992\n29540069\n29540067\n29540068\n29394426\n29360815\n29361201\n29361220\n29361221\n29361159\n29361200\n29243822\n29244010\n29244067\n29244068\n29170416\n29164935\n28737193\n28627392\n28627985\n28627195\n28620905\n28545960\n28460945\n28460942\n28460944\n28460941\n28460943\n28444915\n28344378\n28344379\n28282295\n28282296\n28133124\n28133125\n28133123\n28123077\n28051836\n28047778\n28047777\n28047779\n27909032\n27844690\n27812316\n27812317\n27809085\n27809084\n27783073\n27783072\n27787123\n27771035\n27735759\n27707788\n27696311\n27657263\n27657244\n27641430\n27619527\n27620200\n27593135\n27594003\n27576476\n27576376\n27558963\n27553036\n27535575\n27531204\n27508978\n27509115\n27509116\n26929604\n26929605\n26928168\n26815560\n26815561\n26807662\n26654632\n26573432\n26489700\n26375758\n800340\n800349\n800297\n800303\n800339\n800273\n800272\n800282\n800283\n800284\n800285\n700090\n700091\n800265\n800271\n800274\n800295\n800298\n700087\n700088\n800263\n800264\n700086\n800262\n700084\n\nSuperion Indirect Decompression System 14MM, VF Implant\n101-9814\n00884662000550\nALL Lot/Batch Numbers:\n40222018\n40222380\n40211257\n40186588\n40165998\n40113412\n40113503\n40113583\n40113602\n40113620\n40113621\n40113640\n40106796\n40093429\n40051972\n40045632\n40045657\n40027363\n40018299\n40018362\n40000650\n29262518\n30244395\n30244806\n29985231\n29850095\n29703521\n29547991\n29539391\n29523354\n29393128\n29393129\n29394425\n29170296\n29164945\n29164946\n28756502\n28693439\n28628060\n28627199\n28501594\n28501595\n28336412\n28144010\n27868456\n27735900\n27707785\n27707787\n27535576\n26848047\n26799951\n26619510\n26406210\n26366842\n26323984\n800342\n800300\n800341\n800266\n800287\n800286\n800304\n800275\n800299\n\nSuperion Indirect Decompression System 16MM, VF Implant\n101-9816\n00884662000567\nALL Lot/Batch Numbers:\n40293569\n40198619\n40186436\n40080053\n40070342\n40051973\n40018345\n29703520\n29575558\n27783071\n27535578\n800267\n800343\n800277\n\nSuperion Indirect Decompression System Kit, VF Instrument\n102-9800\n00884662000574\nALL Lot/Batch Numbers:\n40277815\n40277874\n40277890\n40277911\n40278004\n40278100\n40278101\n40276344\n40276407\n40276430\n40276444\n40276525\n40276527\n40276566\n40276587\n40276605\n40276646\n40276663\n40276664\n40271124\n40262838\n40262970\n40263108\n40257898\n40258441\n40258462\n40257952\n40258003\n40258047\n40258067\n40258102\n40258140\n40258141\n40256318\n40256554\n40256555\n40256590\n40256627\n40256645\n40256684\n40256706\n40254134\n40254135\n40254153\n40254211\n40254212\n40254256\n40254257\n40254258\n40254259\n40254274\n40254335\n40254349\n40254350\n40254398\n40254464\n40254465\n40254466\n40254467\n40254521\n40254522\n40254542\n40245657\n40240497\n40240498\n40240793\n40240878\n40240888\n40240931\n40240970\n40240971\n40240972\n40241044\n40241068\n40241105\n40241144\n40241145\n40235666\n40233094\n40232369\n40232387\n40232388\n40232405\n40232429\n40232472\n40232489\n40232495\n40232591\n40232595\n40232653\n40232657\n40225393\n40224452\n40223799\n40223952\n40223953\n40223955\n40223976\n40223995\n40223996\n40224033\n40224035\n40224075\n40224148\n40224151\n40224163\n40224221\n40224222\n40224240\n40224241\n40213780\n40207876\n40207916\n40207958\n40208033\n40208115\n40208135\n40208176\n40208179\n40208192\n40208193\n40208206\n40208242\n40208260\n40208261\n40203693\n40200036\n40200037\n40200038\n40200375\n40200409\n40200489\n40200490\n40200491\n40200541\n40200581\n40200582\n40194379\n40188515\n40188549\n40188550\n40188606\n40188666\n40188745\n40188762\n40188780\n40188781\n40181371\n40170319\n40170702\n40167812\n40167813\n40167838\n40167879\n40167935\n40167958\n40167991\n40168037\n40168049\n40168071\n40168072\n40168110\n40168134\n40168135\n40168152\n40168160\n40168210\n40168211\n40168235\n40168274\n40168276\n40168277\n40168288\n40168304\n40168344\n40168345\n40168362\n40168380\n40160900\n40154501\n40154155\n40154177\n40154197\n40154350\n40154463\n40154520\n40154117\n40154178\n40154191\n40154278\n40154314\n40154323\n40154483\n40154190\n40154249\n40154384\n40149401\n40149057\n40149073\n40149170\n40149189\n40149207\n40149240\n40149285\n40149420\n40148893\n40149032\n40149230\n40149286\n40149331\n40148858\n40149011\n40149113\n40149114\n40149241\n40145762\n40145822\n40143655\n40143716\n40143752\n40143855\n40143871\n40143909\n40143924\n40143946\n40143947\n40143985\n40144020\n40134946\n40133855\n40133897\n40133911\n40133936\n40133937\n40133952\n40133967\n40134027\n40134053\n40134101\n40134102\n40134103\n40133293\n40133296\n40133358\n40133397\n40133447\n40133463\n40133468\n40133469\n40133470\n40133531\n40133532\n40133565\n40133585\n40133642\n40133661\n40133682\n40131356\n40131605\n40130713\n40130814\n40130827\n40130828\n40130871\n40130872\n40130931\n40130949\n40130950\n40130962\n40131001\n40131021\n40131040\n40131041\n40131060\n40130339\n40130608\n40130625\n40130686\n40130724\n40129893\n40129936\n40129951\n40129952\n40130048\n40130049\n40130084\n40129331\n40125198\n40125233\n40125234\n40125279\n40125336\n40125337\n40125371\n40125405\n40125406\n40125422\n40125442\n40125460\n40103890\n40103929\n40103942\n40103965\n40097538\n40097594\n40095880\n40093337\n40093547\n40080113\n40080126\n40070305\n40070324\n40061940\n40061941\n40061942\n40049517\n40049518\n40049532\n40049533\n40049546\n40049582\n40049583\n40049620\n40045674\n40045707\n40045102\n40029126\n40027366\n40027367\n40027380\n40018346\n40018347\n40018348\n40018363\n40018380\n40010115\n40010145\n40010146\n40004039\n40000646\n40000664\n30244392\n30244683\n30244393\n30176679\n30176800\n29985417\n29985418\n29985653\n29985654\n29985656\n29985416\n29927753\n29850126\n29850127\n29850125\n29850124\n29788497\n29668584\n29668719\n29668718\n29668586\n29668589\n29668583\n29623991\n29584313\n29584314\n29584563\n29584564\n29584565\n29583233\n29412417\n29412419\n29412416\n29412418\n29413200\n29394389\n29243962\n29210479\n29194952\n29194950\n29160621\n29160623\n29160624\n29041369\n28992639\n28864332\n28756504\n28756506\n28756505\n28756503\n28731511\n28696720\n28696722\n28696721\n28696723\n28696724\n28696725\n28694129\n28544317\n28545962\n28544318\n28545001\n28544319\n28545000\n28545002\n28436250\n28436249\n28436251\n28426894\n28385093\n28336246\n28192765\n28192766\n28192767\n28137208\n28051837\n27939716\n27939715\n27939717\n27844930\n27695955\n27085645\n27007948\n26960437\n26799950\n26768008\n26654631\n26632676\n26489612\n26406212\n26406211\n26375759\n26374481\n26366778\n26341632\n26323985\n26284114\n26284118\n26267257\n26177045\n26177047\n26177046\n204066\n204105\n204103\n204094\n204085\n204083\n204052\n204044\n204032\n204025\n204019\n\nThe Vertiflex Procedure Instrument Platform, VF Instrument\n140-9800\n00884662000611\nALL Lot/Batch Numbers:\n40285562\n40278696\n40278718\n40278719\n40278759\n40278775\n40278776\n40278831\n40278858\n40278889\n40278926\n40279000\n40279020\n40270458\n40270474\n40270726\n40270727\n40270840\n40262795\n40262839\n40262993\n40262994\n40262995\n40262996\n40263009\n40263048\n40263049\n40263086\n40263131\n40263132\n40263143\n40263144\n40263181\n40263200\n40259198\n40259253\n40259254\n40259315\n40259334\n40259378\n40259419\n40259507\n40259546\n40259564\n40259565\n40259584\n40259601\n40258239\n40258249\n40258295\n40258318\n40258372\n40258391\n40258444\n40258463\n40258481\n40241339\n40241413\n40241458\n40241538\n40241539\n40241550\n40241552\n40241595\n40241650\n40241743\n40241744\n40241762\n40241780\n40232352\n40232370\n40232371\n40232457\n40232474\n40232475\n40232496\n40232511\n40232609\n40232610\n40232611\n40232612\n40232613\n40232635\n40232636\n40232672\n40232700\n40224914\n40224357\n40224372\n40224418\n40224419\n40224453\n40224533\n40224534\n40224569\n40224610\n40224628\n40224645\n40224680\n40209996\n40209998\n40210110\n40210129\n40210261\n40210262\n40210280\n40210281\n40209105\n40209188\n40209291\n40209312\n40209346\n40209347\n40209480\n40209481\n40204291\n40204292\n40204314\n40204525\n40204547\n40203639\n40203739\n40203793\n40203794\n40203838\n40203839\n40203875\n40203945\n40203963\n40203981\n40203982\n40204001\n40204002\n40204021\n40204040\n40204061\n40204080\n40189518\n40189519\n40189617\n40189618\n40189619\n40189656\n40189727\n40189728\n40189729\n40189730\n40189731\n40189747\n40189849\n40189906\n40189940\n40189941\n40171416\n40171417\n40171475\n40171497\n40171516\n40171549\n40171619\n40171708\n40171762\n40171782\n40170898\n40170919\n40170995\n40171088\n40171107\n40171108\n40171163\n40171220\n40171240\n40171241\n40171242\n40171243\n40155518\n40155694\n40155805\n40155880\n40155539\n40155751\n40155825\n40155864\n40155881\n40155598\n40155619\n40155637\n40155647\n40155675\n40155729\n40155750\n40155804\n40155597\n40155693\n40155803\n40150438\n40150619\n40150881\n40150771\n40150784\n40150901\n40150675\n40150727\n40150749\n40150785\n40150882\n40150883\n40150674\n40150696\n40150710\n40150770\n40150783\n40150803\n40150862\n40150880\n40150900\n40150902\n40150709\n40150802\n40149817\n40149796\n40149950\n40149994\n40150031\n40150032\n40150103\n40128791\n40128851\n40128852\n40128931\n40128993\n40129007\n40129008\n40129009\n40129032\n40129063\n40129111\n40129150\n40127593\n40127612\n40127653\n40127685\n40127707\n40127731\n40127771\n40127787\n40127800\n40127827\n40127842\n40127880\n40127900\n40127920\n40127135\n40127197\n40127207\n40127211\n40127231\n40126331\n40106731\n40106946\n40093528\n40093529\n40080127\n40070341\n40061839\n40061876\n40061960\n40049519\n40049547\n40049570\n40049584\n40049603\n40049604\n40045675\n40045692\n40029087\n40027318\n40027347\n40018314\n40018351\n40018381\n40018382\n40010095\n40010113\n40000587\n40000633\n40000634\n30244684\n30244686\n30244685\n29985748\n29985749\n29985750\n29985752\n29985755\n29985758\n29850008\n29850009\n29850007\n29850006\n29668654\n29668699\n29668594\n29668595\n29668593\n29668698\n29584137\n29584560\n29584561\n29584139\n29584562\n29584138\n29448373\n29448375\n29448374\n29448372\n29448371\n29211740\n29211744\n29211743\n29211742\n29211741\n29211745\n28993461\n28993460\n28792503\n28792504\n28792505\n28731513\n28649637\n28650340\n28649639\n28649635\n28649638\n28649636\n28501596\n28501597\n28501598\n28385086\n28385084\n28301015\n28301016\n28301014\n28226777\n28226776\n28226778\n27968504\n27968505\n27968506\n27121980\n27120119\n26897475\n26887527\n26727980\n26574211\n26451355\n26416847\n26366800\n26361434\n26361887\n26323986\n26284115\n26284119\n26177049\n26177744\n26176372\n26177038\n26177050\n26178139\n26178704\n26169429\n26170979\n204106\n204067\n204104\n204095\n204086\n204084\n204053\n204045\n204033\n204026\n204020", "firm_fei_number": "3006630150", "recalling_firm": "Boston Scientific Neuromodulation Corporation", "address_1": "25155 Rye Canyon Loop", "city": "Valencia", "state": "CA", "postal_code": "91355-5004", "additional_info_contact": "Renee Archie\n508-683-4523", "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.", "root_cause_description": "Device Design", "action": "On 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).\n\nCustomer are instructed to:\nPhysicians should stop all implants of the Superion Indirect Decompression System. Further distribution or use of any remaining affected product should cease immediately.\n\nThis 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.\n\n1. Continue to report all device-related incidents or quality concerns experienced with the Superion Indirect Decompression System to Boston Scientific.\n2. Please segregate all Superion Indirect Decompression System product immediately and return it to Boston Scientific in accordance with the enclosed instructions.\nComplete and return the RVTF to get a Return Goods Authorization (RGA) number.\n\"Indicate the quantity of SINGLE units you will be returning for credit\n\"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\n\"Return the RVTF via:\nEmail: BSCFieldActionCenter@bsci.com, or Fax: BSC Field Action Center 1-763-415-7708\n\nPublic Contact - Renee Archie 508-683-4523 or email Renee.Archie@bsci.com", "product_quantity": "70,516", "distribution_pattern": "U.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.", "openfda": { "pma_number": [ "P240043", "P040001", "P140004", "P110008" ], "device_name": "Prosthesis, Spinous Process Spacer/Plate", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3025435185", "3009217531", "3015924373", "1423662", "2029275", "1828288", "2953359", "1450662", "1030489", "3006783837", "9616693", "3005426761", "3010173425", "2133687", "3006630150", "3018094310", "3010160527", "3004142400", "3007766698", "1047843", "3004072627", "3003120897" ], "fei_number": [ "3025435185", "3009217531", "3015924373", "1828288", "3000215205", "3000215273", "1450662", "3009322142", "3005426761", "1000306431", "3002807040", "3006630150", "3018094310", "3000206619", "3002618605", "3004142400", "3002807036", "3007766698", "1047843", "3004072627", "1000477302", "3003120897" ] } } ] }