{ "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": "2026-09-24", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222200", "product_res_number": "Z-3214-2026", "event_date_initiated": "2026-08-24", "event_date_posted": "2026-09-23", "recall_status": "Open, Classified", "res_event_number": "99687", "product_code": "DQO", "k_numbers": [ "K121694" ], "product_description": "Imager II Angiographic Catheters\r\n\r\nM001314001\r\nIMAGER II/5/ST/65/038 BX5;\r\n\r\nM001314011\r\nIMAGER II/5/ST/100/038 BX5;\r\n\r\nM001314021\r\nIMAGER II/5/ST/65/035 BX 5;\r\n\r\nM001314031\r\nIMAGER II/5/ST/100/035 BX 5;\r\n\r\nM001314041\r\nIMAGER II/5/BARNH/100/038 BX5;\r\n\r\nM001314051\r\nIMAGER II/5/BERN/100/038 BX5;\r\n\r\nM001314061\r\nIMAGER II/5/BERN/100/035 BX 5;\r\n\r\nM001314081\r\nIMAGER II/5/BERN/40/038 BX5;\r\n\r\nM001314101\r\nIMAGER II/5/BERN/65/038 BX5;\r\n\r\nM001314141\r\nIMAGER II/5/H1/100/038 BX5;\r\n\r\nM001314151\r\nIMAGER II/5/H1/100/035 BX 5;\r\n\r\nM001314301\r\nIMAGER II/5/SIM1/65/038 BX5;\r\n\r\nM001314321\r\nIMAGER II/5/SIM1/100/038 BX5;\r\n\r\nM001314341\r\nIMAGER II/5/SIM2/100/038 BX5;\r\n\r\nM001314351\r\nIMAGER II/5/SIM2/100/035 BX 5;\r\n\r\nM001314361\r\nIMAGER II/5/SIM3/100/038 BX5;\r\n\r\nM001314521\r\nIMAGER II/5/CHGB/65/038 BX5;\r\n\r\nM001314581\r\nIMAGER II/5/CONTRA 2/65/038 BX5;\r\n\r\nM001314621\r\nIMAGER II/5/C1/65/038 BX5;\r\n\r\nM001314661\r\n00AGER II/5/C2/65/038 BX5;\r\n\r\nM001314671\r\nIMAGER II/5/C2/65/035 BX 5;\r\n\r\nM001314761\r\nIMAGER II/5/MIK/65/038 BX5;\r\n\r\nM001314771\r\nIMAGER II/5/MIK/65/035 BX 5;\r\n\r\nM001314821\r\nIMAGER II/5/SHK1.0/65/038 BX5;\r\n\r\nM001314861\r\nIMAGER II/5/RC2/65/038 BX5;\r\n\r\nM001314881\r\nIMAGER II/5/RDC/65/038 BX5", "code_info": "M001314001\t\t\n\tUDI-DI 08714729354826\t\n\t\tBatches 74B2500089\n\t\t74C2600048\n\t\t74E2500888\n\t\t74G2500942\n\t\t74H2500390\n\t\t74K2400624\n\t\t74K2500754\n\t\t74L2400920\n\nM001314011\t\t\n\tUDI-DI 08714729354833\t\n\t\tBatches 74B2500937\n\t\t74F2500509\n\t\t74L2400427\n\t\t74L2400913\n\t\t74L2500679\n\t\t74M2400314\n\nM001314021\t\t\n\tUDI-DI 08714729354840\t\n\t\tBatches 74A2500370\n\t\t74C2500582\n\t\t74E2500889\n\t\t74E2600070\n\t\t74G2500421\n\t\t74H2500875\n\t\t74K2400982\n\t\t74K2500755\n\t\t74L2500841\n\nM001314031\t\t\n\tUDI-DI 08714729354857\t\n\t\tBatches 74B2501237\n\t\t74D2600727\n\t\t74F2500968\n\t\t74M2400317\n\nM001314041\t\t\n\tUDI-DI 08714729354864\t\n\t\tBatches 74A2500996\n\t\t74B2600070\n\t\t74D2501155\n\t\t74D2600456\n\t\t74G2500951\n\t\t74K2401116\n\nM001314051\t\t\n\tUDI-DI 08714729354871\t\n\t\tBatches 74A2500586\n\t\t74A2500997\n\t\t74B2500090\n\t\t74B2500711\n\t\t74B2500940\n\t\t74B2501238\n\t\t74B2600079\n\t\t74B2600310\n\t\t74B2600390\n\t\t74B2600412\n\t\t74B2600573\n\t\t74C2501047\n\t\t74C2600348\n\t\t74C2600430\n\t\t74C2600531\n\t\t74D2500124\n\t\t74D2500424\n\t\t74D2501156\n\t\t74D2600455\n\t\t74D2600857\n\t\t74D2601116\n\t\t74E2500982\n\t\t74E2501194\n\t\t74F2500511\n\t\t74F2500599\n\t\t74F2500768\n\t\t74G2500422\n\t\t74G2500759\n\t\t74G2501153\n\t\t74G2501349\n\t\t74H2500392\n\t\t74H2500659\n\t\t74H2500665\n\t\t74H2501042\n\t\t74J2500318\n\t\t74J2500552\n\t\t74K2401330\n\t\t74K2500164\n\t\t74K2500756\n\t\t74K2500917\n\t\t74L2400720\n\t\t74L2500033\n\t\t74L2500680\n\t\t74M2400072\n\t\t74M2400304\n\t\t74M2400318\n\t\t74M2500245\n\nM001314061\t\t\n\tUDI-DI 08714729354888\t\n\t\tBatches 74A2500044\n\t\t74A2500587\n\t\t74A2600261\n\t\t74A2600415\n\t\t74B2500091\n\t\t74B2500488\n\t\t74B2600080\n\t\t74B2600895\n\t\t74C2500053\n\t\t74C2500583\n\t\t74C2600350\n\t\t74D2500125\n\t\t74D2500426\n\t\t74D2600575\n\t\t74E2500201\n\t\t74E2500293\n\t\t74E2500981\n\t\t74E2501195\n\t\t74F2500969\n\t\t74G2500778\n\t\t74G2501350\n\t\t74H2501041\n\t\t74J2500085\n\t\t74K2400625\n\t\t74K2500759\n\t\t74L2400041\n\t\t74L2400411\n\t\t74L2400418\n\t\t74L2401248\n\t\t74L2401259\n\t\t74L2500681\n\t\t74L2500831\n\t\t74L2500939\n\t\t74M2400303\n\t\t74M2400305\n\nM001314081\t\t\n\tUDI-DI 08714729354901\t\n\t\tBatches 74A2500375\n\t\t74A2600681\n\t\t74B2500489\n\t\t74B2600042\n\t\t74B2600328\n\t\t74B2600329\n\t\t74C2500584\n\t\t74D2500427\n\t\t74E2500294\n\t\t74E2501196\n\t\t74E2600412\n\t\t74E2600413\n\t\t74F2500722\n\t\t74G2500910\n\t\t74G2500943\n\t\t74G2501351\n\t\t74H2500234\n\t\t74H2501035\n\t\t74K2401069\n\t\t74L2400419\n\t\t74L2400687\n\t\t74L2500359\n\t\t74L2500682\n\t\t74M2400306\n\nM001314101\t\t\n\tUDI-DI 08714729354925\t\n\t\tBatches 74A2500376\n\t\t74A2500461\n\t\t74A2600324\n\t\t74A2600417\n\t\t74A2600680\n\t\t74B2600572\n\t\t74B2600590\n\t\t74B2600840\n\t\t74C2500021\n\t\t74C2500046\n\t\t74C2500585\n\t\t74C2600043\n\t\t74C2600044\n\t\t74C2600532\n\t\t74C2600810\n\t\t74D2500604\n\t\t74D2500682\n\t\t74D2600039\n\t\t74D2600050\n\t\t74D2600578\n\t\t74E2500295\n\t\t74E2501197\n\t\t74E2600071\n\t\t74E2600193\n\t\t74E2600194\n\t\t74E2600870\n\t\t74F2500120\n\t\t74F2500767\n\t\t74F2500970\n\t\t74F2600059\n\t\t74F2600328\n\t\t74G2500476\n\t\t74G2500944\n\t\t74H2500383\n\t\t74J2500170\n\t\t74J2500547\n\t\t74K2400361\n\t\t74K2401070\n\t\t74K2401317\n\t\t74K2500165\n\t\t74K2501039\n\t\t74L2400939\n\t\t74L2401250\n\t\t74L2500367\n\t\t74M2400075\n\t\t74M2500092\n\t\t74M2500571\n\nM001314141\t\t\n\tUDI-DI 08714729354963\t\n\t\tBatches 74A2501084\n\t\t74A2600685\n\t\t74B2600078\n\t\t74B2600575\n\t\t74D2600457\n\t\t74G2500945\n\t\t74K2401113\n\t\t74M2500705\n\nM001314151\t\t\n\tUDI-DI 08714729354970\t\n\t\tBatches 74C2500767\n\t\t74E2600505\n\t\t74F2500121\n\t\t74F2500967\n\t\t74L2401249\n\nM001314301\t\t\n\tUDI-DI 08714729355120\t\n\t\tBatches 74A2500462\n\t\t74A2600059\n\t\t74B2500490\n\t\t74C2500768\n\t\t74C2600046\n\t\t74C2600733\n\t\t74E2500296\n\t\t74F2500971\n\t\t74F2600062\n\t\t74F2600329\n\t\t74G2500190\n\t\t74H2500223\n\t\t74J2500080\n\t\t74K2400362\n\t\t74L2500032\n\t\t74M2500572\n\nM001314321\t\t\n\tUDI-DI 08714729355144\t\n\t\tBatches 74A2500588\n\t\t74B2500491\n\t\t74B2501240\n\t\t74B2600539\n\t\t74C2500769\n\t\t74D2600571\n\t\t74F2500122\n\t\t74G2500191\n\t\t74G2500947\n\t\t74H2500235\n\t\t74L2401251\n\t\t74M2500706\n\nM001314341\t\t\n\tUDI-DI 08714729355168\t\n\t\tBatches 74A2500589\n\t\t74B2500492\n\t\t74B2600591\n\t\t74C2500770\n\t\t74D2500683\n\t\t74D2600572\n\t\t74E2500297\n\t\t74F2500123\n\t\t74G2501345\n\t\t74H2500236\n\t\t74J2500083\n\t\t74K2401321\n\t\t74K2500758\n\t\t74L2400689\n\t\t74M2400065\n\t\t74M2500084\n\t\t74M2500576\n\t\t74M2500708\n\nM001314351\t\t\n\tUDI-DI 08714729355175\t\n\t\tBatches 74A2500590\n\t\t74A2600416\n\t\t74B2500708\n\t\t74C2500771\n\t\t74D2500684\n\t\t74E2500298\n\t\t74E2600507\n\t\t74F2500124\n\t\t74G2500192\n\t\t74G2501346\n\t\t74H2500237\n\t\t74K2401322\n\t\t74M2400066\n\t\t74M2400783\n\t\t74M2500242\n\nM001314361\t\t\n\tUDI-DI 08714729355182\t\n\t\tBatches 74F2500125\n\t\t74M2500709\n\nM001314521\t\t\n\tUDI-DI 08714729355342\t\n\t\tBatches 74E2500646\n\nM001314581\t\t\n\tUDI-DI 08714729355403\t\n\t\tBatches 74A2500463\n\t\t74A2500988\n\t\t74A2600331\n\t\t74A2600683\n\t\t74A2600684\n\t\t74B2500709\n\t\t74C2500772\n\t\t74C2600045\n\t\t74C2600702\n\t\t74D2500685\n\t\t74E2500647\n\t\t74E2600072\n\t\t74F2500126\n\t\t74F2600060\n\t\t74G2500193\n\t\t74H2500384\n\t\t74J2500305\n\t\t74K2400615\n\t\t74K2400616\n\t\t74K2401117\n\t\t74K2501040\n\t\t74L2400424\n\t\t74L2400721\n\t\t74L2400938\n\t\t74L2401290\n\t\t74L2500029\n\t\t74M2400734\n\t\t74M2500093\n\nM001314621\t\t\n\tUDI-DI 08714729355441\t\n\t\tBatches 74A2500990\n\t\t74A2501085\n\t\t74A2501087\n\t\t74D2500686\n\t\t74E2500301\n\t\t74E2500648\n\t\t74F2500127\n\t\t74H2500225\n\t\t74J2500306\n\t\t74K2400617\n\t\t74K2501041\n\t\t74L2400722\n\t\t74L2400915\n\t\t74L2401253\n\t\t74L2500370\n\t\t74M2400078\n\nM001314661\t\t\n\tUDI-DI 08714729355489\t\n\t\tBatches 74A2500993\n\t\t74A2501311\n\t\t74A2600061\n\t\t74A2600682\n\t\t74B2500493\n\t\t74B2500710\n\t\t74C2500047\n\t\t74C2500773\n\t\t74C2600533\n\t\t74D2500687\n\t\t74D2500881\n\t\t74D2600579\n\t\t74E2500649\n\t\t74F2500128\n\t\t74F2500503\n\t\t74G2500194\n\t\t74H2500226\n\t\t74H2500385\n\t\t74J2500086\n\t\t74J2500307\n\t\t74K2400618\n\t\t74K2500166\n\t\t74K2501042\n\t\t74L2400916\n\t\t74L2401254\n\t\t74L2500021\n\t\t74L2500371\n\t\t74L2500683\n\t\t74M2400067\n\t\t74M2400079\n\t\t74M2500573\n\nM001314671\t\t\n\tUDI-DI 08714729355496\t\n\t\tBatches 74A2500111\n\t\t74A2501312\n\t\t74A2600058\n\t\t74C2500048\n\t\t74C2501039\n\t\t74C2600530\n\t\t74D2500882\n\t\t74D2600577\n\t\t74E2500650\n\t\t74F2500504\n\t\t74G2500195\n\t\t74H2500386\n\t\t74J2500308\n\t\t74K2400619\n\t\t74K2401114\n\t\t74K2501165\n\t\t74M2400068\n\t\t74M2500574\n\nM001314761\t\t\n\tUDI-DI 08714729355588\t\n\t\tBatches 74A2501313\n\t\t74C2500774\n\t\t74E2500651\n\t\t74E2500882\n\t\t74F2600061\n\t\t74G2500224\n\t\t74K2500753\n\nM001314771\t\t\n\tUDI-DI 08714729355595\t\n\t\tBatches 74A2501314\n\t\t74C2500049\n\t\t74C2600703\n\t\t74D2500038\n\t\t74D2500883\n\t\t74E2500883\n\t\t74E2600508\n\t\t74E2600869\n\t\t74F2500505\n\t\t74F2600058\n\t\t74G2500333\n\t\t74H2500873\n\t\t74J2500316\n\t\t74J2500549\n\t\t74L2400426\n\t\t74L2500689\n\t\t74M2400069\n\nM001314821\t\t\n\tUDI-DI 08714729355649\t\n\t\tBatches 74A2600702\n\t\t74B2500082\n\t\t74B2600311\n\t\t74C2500050\n\t\t74C2501041\n\t\t74F2500506\n\t\t74K2500163\n\t\t74L2400937\n\nM001314861\t\t\n\tUDI-DI 08714729355687\t\n\t\tBatches 74C2500051\n\t\t74L2400936\n\t\t74M2500086\n\nM001314881\t\t\n\tUDI-DI 08714729355700\t\n\t\tBatches 74E2500884\n\t\t74G2500226\n\t\t74G2500334\n\t\t74J2500311\n\t\t74K2400620\n\t\t74L2500022", "firm_fei_number": "3002095335", "recalling_firm": "Boston Scientific Corporation", "address_1": "1 Scimed Pl", "city": "Maple Grove", "state": "MN", "postal_code": "55311-1565", "additional_info_contact": "Clara Johnson\n763-494-1700", "reason_for_recall": "Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure or life-threatening embolism.", "root_cause_description": "Process control", "action": "Firm began notifying customers on August 24, 2026.\n\nCustomers were instructed to immediately stop further use or distribution and segregate affected product.\n\nCustomers should continue to follow the standard of care when monitoring patients treated with the product.\n\nCustomers were advised to utilize both inner and outer packaging UPN codes when searching for affected product.\n\nCustomers were provided with instructions to return product.", "product_quantity": "262,686", "distribution_pattern": "Worldwide - US Nationwide and territories of Puerto Rico and the countries of Albania, Algeria, Argentina, Australia, Austria, Barbados, Belgium, Brazil, Brunei Dar-es-S, Bulgaria, Cambodia, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, France, Georgia, Germany, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Poland, Portugal, Puerto Rico, Qatar, Rep N Macedonia, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad, Tobago, Tunisia, T¿rkiye, UAE, Ukraine, United Kingdom, USA, W. Bank Gaza Strip, Yemen.", "openfda": { "k_number": [ "K905017", "K010707", "K935402", "K151724", "K842195", "K904959", "K871021", "K863337", "K113737", "K170406", "K171264", "K000743", "K911270", "K841615", "K911560", "K870700", "K894401", "K003901", "K911710", "K160660", "K050684", "K860429", "K173289", "K770290", "K921649", "K875325", "K172635", "K920980", "K844800", "K864943", "K950882", "K024000", "K822100", "K852547", "K962759", "K963335", "K914312", "K781558", "K970854", "K053171", "K021283", "K140356", "K163141", "K083922", "K884354", "K810508", "K832386", "K902943", "K872248", "K895437", "K963092", "K913682", "K232536", "K822594", "K932420", "K023591", "K040776", "K883051", "K833554", "K000659", "K101625", "K862244", "K232573", "K902771", "K050577", "K875337", "K882796", "K952773", "K171355", "K060175", "K061565", "K852197", "K063312", "K950855", "K123818", "K770868", "K993694", "K913364", "K960975", "K903199", "K011217", "K853182", "K230620", "K912270", "K230411", "K073585", 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