{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "169712", "product_res_number": "Z-0700-2019", "event_date_initiated": "2018-11-28", "event_date_created": "2019-01-08", "recall_status": "Open, Classified", "res_event_number": "81747", "product_code": "OAD", "pma_numbers": [ "P150005S005" ], "product_description": "IntellaTip MiFi Open-Irrigated Ablation Catheter\n\nProduct Usage:\nOpen Irrigated ablation catheters, when used with a compatible Radiofrequency (RF) Controller and Irrigation Pump, are indicated for: Cardiac electrophysiological mapping Delivering diagnostic pacing stimuli RF ablation of sustained or recurrent type 1 Atrial Flutter in patients age 18 years or older Treatment of drug refractory, recurrent, symptomatic, paroxysmal atrial fibrillation (PAF) in patients age 18 years or older, when used with a compatible mapping system", "code_info": "IntellaTip MiFi Open-Irrigated Ablation Catheter Material Number: M004PM96200 Batch:\t20368736\tExpiration Date:\t3/5/2020 Batch:\t20531648\tExpiration Date:\t4/16/2020 Batch:\t20560477\tExpiration Date:\t4/23/2020 Batch:\t20566637\tExpiration Date:\t4/24/2020 Batch:\t20628704\tExpiration Date:\t5/9/2020 Batch:\t20628705\tExpiration Date:\t5/10/2020 Batch:\t20763900\tExpiration Date:\t6/12/2020 Batch:\t20769113\tExpiration Date:\t6/13/2020 Batch:\t21318000\tExpiration Date:\t10/29/2020 Batch:\t21318001\tExpiration Date:\t10/29/2020 Batch:\t21357647\tExpiration Date:\t11/10/2020 Batch:\t21463186\tExpiration Date:\t12/3/2020 Batch:\t21543193\tExpiration Date:\t12/20/2020 Batch:\t21574774\tExpiration Date:\t1/4/2021 Batch:\t22195929\tExpiration Date:\t5/31/2021 Batch:\t22202991\tExpiration Date:\t6/3/2021 Batch:\t22290601\tExpiration Date:\t6/3/2021 Batch:\t22305067\tExpiration Date:\t6/25/2021 Batch:\t22315782\tExpiration Date:\t6/27/2021 Batch:\t22317356\tExpiration Date:\t6/28/2021 Batch:\t22327178\tExpiration Date:\t7/1/2021 Batch:\t22329367\tExpiration Date:\t7/2/2021 Batch:\t22330626\tExpiration Date:\t7/2/2021 Batch:\t22371866\tExpiration Date:\t7/12/2021 Batch:\t22371868\tExpiration Date:\t7/12/2021 Batch:\t22379905\tExpiration Date:\t7/15/2021 Batch:\t22435929\tExpiration Date:\t7/26/2021 Batch:\t22435930\tExpiration Date:\t7/26/2021 Batch:\t22438118\tExpiration Date:\t7/27/2021 Batch:\t22455198\tExpiration Date:\t7/31/2021 Batch:\t22499957\tExpiration Date:\t8/10/2021 Material Number: M004PM9620K20 Batch:\t20371559\tExpiration Date:\t3/6/2020 Batch:\t20542305\tExpiration Date:\t4/18/2020 Batch:\t20548241\tExpiration Date:\t4/19/2020 Batch:\t20639975\tExpiration Date:\t5/14/2020 Batch:\t20677314\tExpiration Date:\t5/21/2020 Batch:\t20772834\tExpiration Date:\t6/14/2020 Batch:\t22321772\tExpiration Date:\t6/29/2021 Batch:\t22326857\tExpiration Date:\t7/1/2021 Material Number: M004PM9620N40 Batch:\t20371742\tExpiration Date:\t3/8/2020 Batch:\t20463744\tExpiration Date:\t3/28/2020 Batch:\t20622763\tExpiration Date:\t5/8/2020 Batch:\t20775597\tExpiration Date:\t6/14/2020 Batch:\t22340824\tExpiration Date:\t7/4/2021 Batch:\t22371871\tExpiration Date:\t7/12/2021 Batch:\t22374909\tExpiration Date:\t7/13/2021", "firm_fei_number": "3004859241", "recalling_firm": "Boston Scientific Corporation", "address_1": "300 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1291", "reason_for_recall": "Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.", "root_cause_description": "Nonconforming Material/Component", "action": "On November 28, 2018, Boston Scientific sent Urgent Medical Device Removal - Immediate Action Required letters to their Japanese consignees requesting them to check and segregate any of the recalled product. The letter also asked the consignees to conduct sub-recalls, if necessary, and to return The Reply Verification Tracking Form.", "product_quantity": "1,282 (all three types in Japan)", "distribution_pattern": "Japan", "openfda": { "pma_number": [ "P150005", "P040042", "P110016", "P020025", "P050024", "P030031", "P010068", "P950005", "P060019" ], "registration_number": [ "3013403214", "3001592626", "3015537323", "1000121056", "3019807891", "3000279201", "3007029079", "2030404", "1721686", "9680001", "9673241", "2032098", "3012179728", "1643817", "2032112", "2182208", "3005334138", "3016245399", "3004105270", "2124215", "1721504", "3008452825", "2184149", "3001763079", "3007695959", "3017060084", "1928237", "3008328679", "1319639", "2028523", "3012552532", "3013581838", "3004859241", "2182269", "3010705768", "3010273872", "3004016520", "3002807314", "9681260", "3010280625", "3009243923", "3012260771", "3010291427", "1721983", "3008093809", "1650907", "3012520654", "3006634485", "3010653929", "3011120183", "3013300026", "9612164" ], "fei_number": [ "3013403214", "1000138054", "3003076831", "3015537323", "1000121056", "3019807891", "3001592626", "3000279201", "3007029079", "1721686", "3012179728", "1643817", "1000139754", "2182208", "3005334138", "3016245399", "3004105270", "2124215", "1721504", "3008452825", "3001763079", "3007695959", "3002806565", "3017060084", "1928237", "3008328679", "1000125147", "3012552532", "3013581838", "3002806434", "3004859241", "2182269", "3010705768", "3010273872", "3003248396", "3002808445", "3004016520", "1000519796", "3002807314", "3010280625", "3009243923", "3003058448", "3012260771", "3010291427", "3002681132", "1000064530", "3008093809", "3012520654", "3006634485", "3010653929", "3011120183", "3013300026" ], "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ] }