{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196175", "product_res_number": "Z-0146-2023", "event_date_initiated": "2022-10-06", "event_date_posted": "2022-10-28", "recall_status": "Open, Classified", "res_event_number": "90905", "product_code": "DXE", "k_numbers": [ "K193379" ], "product_description": "Fogarty Arterial Embolectomy Catheters Model Number:\n120602FP\n120403FP \n120803FP\n120404FP\n120804FP\n120805FP\n120806FP\n120807FP\n\nFogarty Arterial Embolectomy Catheter with Stylet Model Number:\n120403FSP\n120803FSP", "code_info": "Fogarty Arterial 120403FP Embolectomy Catheters\nModel Number / UDI-DI Code:\n120602FP / 00690103205206\nLot Numbers:\n63325817\n63412990\n64049166\n64052416\n64320468\n64311217\n64286041\n64075556\n64085285\n64124889\n64180619\n63914203\n63967960\n63266275\n63281593\n63449645\n63560630\n63612077\n63626926\n63738860\n63735762\n63750304\n63772968\n63724845\n63914201\n63892007\n63967950\n63990050\n64027881\n64036551\n64052415\n64063487\n64124888\n64173669\n64180620\n64180548\n64332505\n64344742\n63907174\n64099010\n64099008\n63420190\n63435603\n63476159\n63511721\n63600508\n63611742\n63669399\n63750303\n63735818\n63850952\n63907175\n63944429\n63984736\n63944467\n63907167\n64014108\n63995701\n64036698\n64075555\n64180549\n64173668\n64110676\n64205522\n64220842\n64252735\n64231811\n64231810\n64264792\n64274428\n64297806\n64297810\n64321021\n64321020\n63281591\n63375216\n63420189\n63464807\n63501933\n63560629\n63634785\n63612076\n63914359\n64193163\n64266393\n64239056\n63375217\n64059266\n64252737\n63735761\n63412989\n63600507\n63633312\n63990049\n64193162\n64205539\n64383524\n64394451\n63611743\n63352974\n63386855\n63340743\n63349810\n63432009\n63449644\n63476158\n63435604\n63487678\n63464806\n63513249\n63612073\n63612074\n63560631\n63669400\n63612075\n63661028\n63670579\n63670029\n63670031\n63712780\n63687299\n63712779\n63670028\n63776322\n63797464\n63892006\n63850950\n63856376\n63883760\n63883761\n63944427\n63954394\n63990047\n63990048\n64025093\n64063485\n64099009\n64180550\n64383526\n64243759\n64205521\n64273885\n64239057\n64276520\n64252736\n64274714\n64297805\n64264793\n64286039\n64343086\n64354938\n64368268\n64368267\n64085286\n64344743\n64354939\n\n120403FP / 00690103205084\nLot Numbers:\n63281594\n63420192\n63293457\n63292302\n63435605\n63227617\n63266276\n63851020\n64180623\n64063399\n64180621\n64173655\n64349486\n64274431\n63735809\n63600513\n63611735\n63611730\n63612145\n63612148\n63612150\n63750306\n63851019\n63967943\n64049155\n64085389\n64205542\n63412996\n63646477\n63626918\n63851013\n64075580\n64286055\n63449646\n63523069\n63801880\n64220844\n63525902\n63669388\n63243860\n63292299\n63243604\n63508558\n63511555\n63611731\n63600510\n63611734\n63554739\n63600511\n63600512\n63614211\n63612144\n63612149\n63626919\n63724825\n63724827\n63735752\n63735810\n63772972\n63851016\n63851015\n63851017\n63851018\n63883814\n63944461\n63892043\n63914365\n63954398\n63967944\n63967942\n63990042\n63995709\n64037831\n64052468\n64099018\n64099015\n64110682\n64124920\n64180560\n64180559\n64180622\n64205543\n64252738\n64297812\n64311232\n64180561\n\n120803FP / 00690103205091\nLot Numbers:\n63281615\n63301866\n63293544\n63449651\n63281616\n63540578\n64014116\n64036550\n64085388\n64173662\n64180628\n64239085\n64193189\n64228631\n64311235\n64231815\n64063488\n64180563\n64180627\n63670047\n63883800\n63914374\n63892047\n63990053\n64368271\n64349489\n63883785\n63883787\n63998710\n64017928\n64231982\n64193181\n64231983\n64252743\n64297822\n63281612\n63266279\n63304187\n63266281\n63266282\n63386864\n63501940\n63612157\n63661024\n63751152\n63751153\n63751155\n63776326\n63990044\n63990045\n64075767\n64110680\n64311241\n63669391\n63677169\n63670050\n63735803\n63670049\n63851025\n63851026\n63375226\n63266280\n63612155\n63634613\n63626908\n63661023\n63892046\n64052470\n64063490\n64085387\n64110678\n64110679\n64124922\n64124900\n64231981\n63298984\n63239466\n63266283\n63386863\n63386862\n63449653\n63540575\n63566182\n63566181\n63626907\n63661021\n63661025\n63670042\n63990052\n64052471\n64036700\n64049148\n64063489\n64124899\n64075768\n64075769\n64075770\n64165221\n64180564\n64180626\n64286058\n64311236\n63612159\n63525901\n63778897\n63364602\n63386869\n63412994\n63487681\n63501936\n63540576\n63540577\n63600515\n63772970\n63751167\n63724835\n63990046\n63856382\n64231814\n63707884\n63281611\n63281614\n63375224\n63301865\n63325826\n63357626\n63375222\n63375223\n63481504\n63449650\n63386860\n63412998\n63412997\n63412999\n63464809\n63487680\n63239464\n63501935\n63501937\n63501939\n63540579\n63540581\n63540582\n63540580\n63554746\n63549889\n63554743\n63566180\n63600514\n63611737\n63612154\n63612158\n63612156\n63626909\n63669392\n63669393\n63669394\n63670048\n63670044\n63701954\n63670043\n63670045\n63611736\n63670046\n63707886\n63998713\n63707885\n63720568\n63720569\n63735742\n63735743\n63735744\n63776325\n63856386\n63883799\n63883786\n63914372\n63914209\n63944415\n63944416\n63944413\n63944414\n63944417\n63984731\n63954397\n63967939\n63990043\n63998711\n63995708\n64025077\n64025078\n64025076\n64036699\n64052572\n64124901\n64170458\n64165222\n64170459\n64180562\n64180565\n64180625\n64193185\n64193182\n64193184\n64193183\n64220848\n64193180\n64205551\n64205550\n64220847\n64228630\n64239086\n64239087\n64252742\n64287027\n64332513\n64354942\n64368272\n64252745\n64332514\n64394457\n64437468\n64321034\n64332512\n\n120404FP / 00690103205107\nLot Numbers:\n63316243\n63266182\n63412917\n63447531\n63386786\n63431368\n63449609\n63266183\n63464776\n64049163\n64052436\n64193102\n64269069\n64098037\n64297683\n64052343\n64102638\n64075502\n64180580\n64052438\n64180581\n64289824\n63266184\n63776293\n63779313\n63712318\n63744071\n63883295\n63883298\n63891423\n63967940\n64085229\n64098969\n63883297\n63954328\n64036656\n64180497\n63375235\n63266187\n63375233\n63523032\n63669373\n63669372\n63669375\n63669450\n63677010\n63883293\n63954330\n63998630\n63998649\n64075503\n63523031\n63670567\n63850871\n63850944\n64014032\n64098970\n63375234\n63325721\n63325722\n63266185\n63266186\n63386785\n63386787\n63484847\n63611718\n63611709\n63612665\n63633256\n63611710\n63611717\n63613958\n63612519\n63634526\n63670558\n63612661\n63612662\n63612663\n63612664\n63669374\n63797445\n63669949\n63669950\n63687362\n63687361\n63944457\n63735746\n63772848\n63797446\n63850940\n63850925\n63856326\n63891421\n63891422\n63914292\n63944418\n63954327\n63954329\n63996461\n63967954\n63996462\n63996463\n64013516\n64049149\n64110621\n64235882\n64205453\n64220812\n64231975\n64289816\n64289830\n64302644\n64297076\n64285989\n64297079\n64180496\n64332474\n64354883\n64367857\n64367856\n64367859\n64457671\n\n120804FP / 00690103205213\nLot Numbers:\n63349774\n63349775\n63158527\n63449617\n63502089\n63349776\n63412930\n63420128\n63435526\n63707881\n64036540\n64036679\n64049164\n64085232\n64180590\n64173640\n64252689\n64252690\n64274410\n64285995\n64285992\n64320982\n64036538\n64205460\n64311189\n64063474\n64075525\n64085244\n64173639\n64180587\n64180501\n64180586\n63669378\n63944470\n63914323\n63914324\n63998618\n63944425\n63944464\n64027787\n64014034\n63998619\n63776284\n63735816\n63914300\n63995681\n64027785\n63998650\n63316255\n63310745\n63301457\n63316256\n63349777\n63408651\n63340195\n63518665\n63626923\n63633261\n63669968\n63669974\n63735759\n63797452\n63856327\n63883274\n63914295\n64049158\n64052346\n64098973\n64098974\n64180502\n64205461\n64344512\n63681741\n63669966\n63695259\n63633264\n63633257\n63669965\n63720549\n63633262\n63735757\n63797633\n63883278\n63883275\n64014030\n64075524\n64049160\n64049161\n64063476\n64098975\n64110626\n64193109\n64205459\n64252683\n64264746\n64344515\n64264744\n63408652\n63612523\n63316250\n63316252\n63316254\n63612524\n64173638\n63306291\n63306430\n63340221\n63364540\n63349778\n63412928\n63412929\n63518667\n63626927\n63633265\n63677012\n63850873\n63850946\n63856354\n63883272\n63883273\n64140000\n64220814\n64025086\n63316259\n63357479\n63357475\n63357478\n63316258\n63316257\n63325723\n63340220\n63340230\n63349773\n63449618\n63408657\n63375245\n63375252\n63375251\n63386791\n63431713\n63431711\n63487615\n63518663\n63523057\n63502109\n63502108\n63502106\n63600432\n63600431\n63600433\n63600435\n63600438\n63600436\n63600443\n63600442\n63611720\n63611721\n63611722\n63612529\n63626922\n63626928\n63626924\n63626921\n63633263\n63669377\n63669975\n63669967\n63669970\n63735758\n63669969\n63677011\n63707880\n63687367\n63720548\n63779337\n63735815\n63712338\n64036658\n63776282\n63776283\n63776285\n63852650\n63850868\n63797632\n63850927\n63850941\n63856329\n63883271\n63891431\n63913712\n63913713\n63914296\n63914297\n63998629\n63914298\n63954332\n63967956\n63967987\n63967988\n63967957\n63967989\n63998628\n63995679\n63998627\n63998626\n63998616\n64013533\n63998651\n64025084\n64025087\n64036668\n64025088\n64025089\n64025090\n64025091\n64025092\n64036669\n64036672\n64049159\n64075526\n64085243\n64075527\n64110627\n64139995\n64139999\n64173637\n64180504\n64180503\n64180589\n64180588\n64193110\n64193111\n64193112\n64231977\n64231976\n64238950\n64252684\n64252686\n64274409\n64297687\n64311188\n64311191\n64311190\n64285993\n64320983\n64354894\n64393998\n64394004\n64405975\n64405978\n\n120805FP / 00690103205220\nLot Numbers:\n63325740\n63431899\n63412921\n63995680\n63998608\n64014033\n64285999\n64285997\n64231795\n64238960\n64063482\n64098984\n64063360\n64173647\n64231724\n64205465\n64205464\n64052348\n64110622\n63712340\n63852652\n63850945\n63944419\n64344670\n63918798\n63891430\n63984701\n63944420\n63998640\n63995682\n63954331\n63420141\n63292125\n63364537\n63364539\n63386792\n63435528\n63449619\n63518673\n63420142\n63456233\n63669382\n63669984\n63738815\n63687368\n63750283\n63789601\n63944462\n63967955\n64063483\n64110624\n64193125\n63738816\n63755559\n63998613\n63435531\n63435530\n63475963\n63481516\n63518668\n63626920\n63669381\n63669380\n63669980\n63750284\n63750286\n63755558\n63755557\n63776287\n63944423\n64036678\n64124858\n64075530\n64098983\n64231979\n64238951\n64238952\n64252692\n64264747\n63349757\n63612669\n63669981\n63776288\n63776289\n63998654\n64063481\n64180512\n64238953\n63431901\n63420140\n63435532\n63518670\n63325739\n63303010\n63292126\n63325741\n63430449\n63431751\n63447575\n63412920\n63447574\n63435529\n63447579\n63485940\n63518671\n63518672\n63612668\n63420143\n63518669\n63669983\n63420144\n63600430\n63611725\n63612528\n63612521\n63707883\n63612522\n63720566\n63669982\n63850872\n63707882\n63677013\n63724804\n63712339\n63735754\n63735753\n63735811\n63735812\n63776286\n63789642\n63789643\n63852653\n63914301\n63944422\n63944424\n63944421\n63998639\n63998638\n64049157\n64052345\n64110625\n64110623\n64124859\n64150107\n64173646\n64173645\n64180513\n64274411\n64193123\n64193127\n64252693\n64252694\n64297690\n64297689\n64311195\n64320994\n64385781\n64344580\n\n120806FP / 00690103205237\nLot Numbers:\n63357594\n63357593\n63420147\n64063364\n64173648\n64180591\n64014035\n64205467\n64063363\n64098991\n64205466\n64231980\n64344676\n63712342\n63850874\n63913720\n63998641\n64231805\n63883326\n63883325\n64354898\n63292129\n63292127\n63431914\n63420146\n63687372\n63431920\n63883322\n63944428\n63998607\n64274415\n64320996\n63944466\n63292128\n63412923\n63626929\n63677015\n63750287\n63755566\n63850947\n63883328\n63856364\n63883323\n64075772\n64075783\n64124861\n64238969\n64291999\n64297691\n63386793\n63735817\n63852678\n63998656\n64036546\n64238967\n63669385\n63669987\n63669988\n63954333\n64238970\n63349758\n63612682\n63301465\n63301468\n63325725\n63340209\n63612525\n63612687\n63612530\n63669384\n63612683\n63626925\n63724806\n63687371\n63724805\n63712341\n63735760\n63850869\n63850928\n63850942\n63944426\n63944465\n63967949\n63995684\n63998606\n64049162\n64049165\n64052350\n64052347\n64110630\n64124918\n64231798\n64231799\n64249780\n64238968\n64286010\n64274416\n64320997\n\n120807FP / 00690103201789\nLot Numbers:\n63358177\n64014029\n64085236\n64098989\n64274422\n64173650\n64052344\n64098990\n64442107\n63677017\n63687370\n63967936\n63998642\n63883330\n63883329\n63292133\n63412924\n63883331\n63998602\n64049150\n64063365\n64205468\n64231806\n63755565\n63735748\n64124862\n64231807\n64274421\n63850926\n64036677\n64075532\n64220819\n63364535\n63431933\n64193136\n63301763\n63386798\n63431931\n63449620\n63611727\n63612520\n63634654\n63626903\n63677018\n63724815\n63712345\n63856365\n63944458\n63954337\n63995685\n64085237\n64286011\n64297692\n64320999\n64274423\n64437339\n64344678\n\nFogarty Arterial Embolectomy Catheter with Stylet\nModels Number / UDI-DI Code:\n120403FSP / 00690103205190\nLot Numbers:\n63281613\n63292303\n63456457\n64063400\n63281617\n63281618\n63851022\n63435606\n63856379\n63967948\n63990055\n63892044\n64014118\n64075582\n63967953\n63914205\n64124895\n64014119\n63724828\n64173656\n64173657\n64180624\n64248137\n64368269\n63856380\n64085390\n63449654\n63364603\n64220845\n\n120803FSP / 00690103205244\nLot Numbers:\n63292306\n63316450\n63325827\n63325828\n63364604\n63851032\n63914366\n63914211\n63975628\n64099016\n64110683\n64205557\n64228638\n64280765\n63266285\n63316451\n63357903\n63420194\n63420195\n63420196\n63316452\n63456475\n63456496\n63456472\n63420193\n63456497\n63720572\n63349821\n63435611\n63687388\n63724837\n63735634\n63735633\n63735635\n63735763\n63735755\n63735813\n63776327\n63851029\n63851030\n63883801\n63851028\n63851027\n63930591\n63945551\n63932061\n63883809\n63892049\n63914210\n63930592\n63944463\n63954399\n63984734\n63944469\n64025799\n64025800\n63984735\n63995712\n64014120\n64014117\n64052420\n64063404\n64124910\n64173664\n64173663\n64205559\n64205558\n64220849\n64252746\n64228636\n64231986\n64264819\n64264816\n64286059\n64264815\n64286061\n63724838\n63670051\n63883803\n63892048\n63967947\n64231816\n64239090\n64252747\n64239091\n64297825\n63266286\n63611738\n63735637\n64025801\n63449655\n63612161\n63990056", "firm_fei_number": "2015691", "recalling_firm": "Edwards Lifesciences, LLC", "address_1": "1 Edwards Way", "city": "Irvine", "state": "CA", "postal_code": "92614-5688", "additional_info_contact": "Linnette Torres\n949-756-4582", "reason_for_recall": "Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.", "root_cause_description": "Packaging", "action": "On 10/06/2022, Edwards Lifesciences sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via FedEx 2nd Day to customer informing them that certain lots of Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes are exhibiting latex deterioration in the balloon. It was determined that storage of these devices in the same room room as high energy ionizing radiation sources which can act as an ozone generator to the immediate environment, can accelerate latex deterioration and subsequent balloon failures.\n\nAdvice on action to be taken by users:\nIt is requested that they do not store Fogarty arterial embolectomy catheters and Fogarty biliary balloon probes in rooms with high energy ionizing radiation sources that could generate ozone (e.g. Fluoroscopy machines, X-ray machines, UV lights, HVAC sanitation equipment, etc). Post the attached notification as a constant reminder to their staff of the issue.\n- If they have devices that have been exposed to the equipment described above, please return the affected inventory with the model and lot number referenced above.\n- If they have devices that have not been exposed to the equipment above (e.g. stored away\nfrom high energy ionizing radiation source), they may continue to use the devices per the IFU.\nReview their inventory and quarantine any exposed product until prepared for return to Edwards Lifesciences. Follow the instructions included in the enclosed customer\nacknowledgement form and return within 5 days of receipt of this notification.\n\nEdwards Customer Service 1-800-424-3278 from 5:00 a.m. to 4:30 p.m. PST.", "product_quantity": "715,620 units", "distribution_pattern": "Worldwide distribution - 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, Puerto Rico, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. The countries of Albania, Argentina, Australia, Austria, Bahamas, Bahrain, Belgium, Bulgaria, CANARY ISLANDS, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Guam, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Lebanon, Malaysia, Malta, Mauritius, Morocco, Netherlands, Nicaragua, Northern Ireland, Oman, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates (UAE), United Kingdom.", "openfda": { "k_number": [ "K900311", "K202049", "K954760", "K897184", "K864062", "K020634", "K973465", "K935405", "K812640", "K891021", "K883852", "K920823", "K971314", "K914880", "K081573", "K972511", "K240078", "K163353", "K193379", "K992368", "K100842", "K902327", "K910372", "K872485", "K241330", "K850015", "K022145", "K901502", "K950586", "K982141", "K972623", "K832023", "K853625", "K770569", "K970657", "K901625", "K894681", "K920871", "K973477", "K780762", "K801650", "K972572", "K961716", "K233820", "K011783", "K992934", "K780244", "K905139", "K864330", "K163031", "K761031", "K961883", "K955125", "K213771", "K832044", "K892410", "K992933", "K152335", "K233819", "K961992", "K790838", "K881455", "K970762", "K820646", "K901627", "K893680", "K233619", "K840198", "K864007", "K770714", "K992940", "K002627", "K974335", "K100840" ], "registration_number": [ "", "3013666218", "3015859709", "2024311", "9617465", "1061124", "1220948", "3011137372", "3030714660", "1220452", "3035111606", "1000393132", "2027111", "3010041511", "1018233", "1721686", "3005704822", "3008496528", "2029386", "1319639", "2183744", "8043983", "1721504", "3032916632", "9680794", "3006082230", "9615817", "2522007", "2015691", "3009051888", "2183870", "1820334", "2648045", "3012050423" ], "fei_number": [ "", "1000138054", "3013666218", "3015859709", "2024311", "3003081151", "1220948", "1220452", "3030714660", "3035111606", "3016261803", "1000393132", "2027111", "3003769549", "3010041511", "1018233", "1721686", "3005704822", "3008496528", "1000512168", "3003737899", "2183744", "1000306647", "1721504", "3032916632", "3005747797", "3006082230", "2522007", "2015691", "3009051888", "2183870", "1820334", "2648045", "3012050423" ], "device_name": "Catheter, Embolectomy", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5150", "device_class": "2" } } ] }