{ "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": "216037", "product_res_number": "Z-0112-2026", "event_date_initiated": "2025-09-10", "event_date_posted": "2025-10-10", "recall_status": "Open, Classified", "res_event_number": "97595", "product_code": "OAE", "pma_numbers": [ "P220013" ], "product_description": "TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter", "code_info": "GTIN 05415067034618, Batch Numbers: 10093213, 10093588, 10095366, 10096269, 10118676, 10131389, 10151333, 10180969, 10286877, 10315661, 10317649, 10329929, 10332297, 10344177, 10350400, 10360030, 10374171, 10375844, 10418954, 10431765, 10433617, 10450462, 10492093, 10494298, 10537000, 10537747, 10538321, 10557710, 10557878, 10558450, 10559655, 10569703, 10570507, 10571902, 10571907, 10574230, 10575746, 10575752, 10577567, 10578953, 10579724, 10580699, 10581612, 10581681, 10583203, 10583793, 10587033, 10587043, 10587653, 10589068, 10589921, 10591178, 10591238, 10592227, 10606628, 10606720, 10608438, 10608708, 10611469, 10611683, 10612686, 10614973, 10616329, 10618038, 10619154, 10621180, 10622172, 10622962, 10622967, 10625101, 10630682, 10630687, 10632744, 10633145, 10634830, 10636059, 10637023, 10639373, 10639374, 10639376, 10639377, 10641739, 10641741, 10642345, 10643887, 10644681, 10645838, 10646429, 10648576, 10662844, 10665077, 10666137, 10667210, 10667217, 10668065, 10668185, 10670353, 10670360, 10671604, 10671663, 10672934, 10674544, 10675329, 10675541, 10677719, 10677722, 10678784, 10680052, 10680962, 10684449, 10691502, 10691504, 10691507, 10692805, 10696082, 10696083, 10696084, 10705825, 10708749, 10708800, 10709735, 10711022, 10711803, 10712639, 10712641, 10714607, 10714611, 10715850, 10717049, 10717050, 10719520, 10721238, 10721239, 10725441, 10725442, 10747196, 10749817, 10749820, 10749823, 10751484, 10762186, 10762464, 10764517, 10764523, 10765657, 10766897, 10767820, 10769643, 10770889, 10772623, 10772625, 10773775, 10773811, 10776251, 10777548, 10778157, 10779451, 10808389, 10808390, 10808393, 10811066, 10811067, 10811262, 10821034, 10827717, 10829276, 10829990, 10830744, 10832015, 10832019, 10832727, 10834411, 10834412, 10835187, 10836468, 10836482, 10836911, 10837558, 10837559, 10839959, 10839960, 10841679, 10841690, 10842962, 10845198, 10845199, 10846600, 10847688, 10847695, 10850757, 10850761, 10856004, 10856065, 10858260, 10867490, 10867495, 10868706, 10873737, 10873924, 10875772, 10875773, 10877194, 10897765, 10899500, 10899504, 10902557, 10902569, 10905178, 10905907, 10906368, 10907259, 10909995, 10910050, 10911332, 10911333, 10913977, 10915227, 10915230, 10920111, 10922315, 10922528, 10924643, 10924802, 10927218, 10954504, 10954507, 10955716, 10956520, 10956521, 10958150, 10959364, 10959373, 10960184, 10962699, 10965714, 10970014, 10970054, 10985513, 10989401, 10990017, 10990759, 10992074, 10992078, 10987781.", "firm_fei_number": "3005334138", "recalling_firm": "Abbott", "address_1": "5050 Nathan Ln N", "city": "Plymouth", "state": "MN", "postal_code": "55442-3209", "additional_info_contact": "Shelley Lange\n651-756-4091", "reason_for_recall": "Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.", "root_cause_description": "Package design/selection", "action": "Abbott issued a Medical Device Advisory to its consignees on 09/10/2025 by letter delivered via Federal Express. The notice explained the issue, impact and associated risk to the patient and requested the following: \n\"Action Requested/Recommendations/Next Steps\n. Continue following the product IFU by inspecting the packaging and catheter for damage and/or kinking prior to use.\n. Review the guidance in Appendix A information on proper removal technique of the TactiFlex\" Ablation Catheter, Sensor Enabled\" from the packaging tray, ensuring to inspect the electrodes and catheter tip carefully for integrity and overall condition prior to use.\n. Abbott has made changes to the packaging tray design to help mitigate tip damage during catheter removal from the packaging. The deployment of the new packaging has begun.\nPlease complete the provided Acknowledgement Form with the assistance of your Abbott representative. This form ensures you are aware of the advisory notice and have been given an opportunity to ask questions. \nPlease forward this notice to anyone in your organization who may need to be notified and maintain this notice for your records to ensure effectiveness of this communication.\nShould you have questions about this issue, please contact your local Abbott representative or Abbott Support at 1-855-478-5833 (U.S), 8:30 a.m. - 5:30 p.m. Central Standard Time, Monday thru Friday.\"", "product_quantity": "11810 units", "distribution_pattern": "Worldwide", "openfda": { "device_name": "Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "pma_number": [ "P220013", "P100010", "P990071", "P150026", "P030031", "P150005", "P200028", "P210027", "P130026", "P220032" ], "registration_number": [ "2184149", "9680001", "3016245399", "3017060084", "2032098", "3002807314", "3005402529", "3007603855", "3012179728", "3005334138", "3012263546", "1650907", "1721676", "3044156918", "9673241", "3004063494", "1000121056", "3004016520", "3010273872", "2124215", "3002648230", "1222616", "3004859241", "3012260771", "1721983", "1225698", "1643817", "3009243923", "3009504230", "9617601", "3001592626", "3012693387", "2024024", "2032112", "3027305778", "3013403214", "1721686", "9681260", "3004105270", "3010653929", "3013300026", "3008452825", "3006891611", "1319639", "3015544746", "2649622", "3007029079", "3000279201", "2182208", "3010705768", "2028523", "3012520654", "3008093809", "9611665", "3017128979", "3004593495", "1928237", "2133810", "3011120183", "9612164", "3015289131", "3012552532", "3008328679", "3015537323" ], "fei_number": [ "3016245399", "3017060084", "3007603855", "3002807314", "3005402529", "3002534070", "3012179728", "1000138054", "3003076831", "3005334138", "3012263546", "1721676", "1000120916", "3003058448", "1000125147", "3000203066", "3044156918", "3004063494", "3002806434", "1000121056", "3004016520", "3010273872", "2124215", "3002648230", "3002681132", "3004859241", "3003248396", "3012260771", "1000139754", "1643817", "3009243923", "3009504230", "3001592626", "3002808445", "3012693387", "2024024", "3027305778", "1000064530", "3013403214", "1721686", "3004105270", "3010653929", "3013300026", "3008452825", "3006891611", "3015544746", "3002806565", "2649622", "3000279201", "3007029079", "3002807095", "2182208", "3010705768", "3001451473", "3012520654", "3008093809", "3017128979", "3004593495", "1928237", "3011120183", "3015289131", "3012552532", "3008328679", "3015537323" ] } } ] }