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Abbott: TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter

Medical DevicesSource: FDA (device) · Date: 2025-10-22

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Abbott
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Reason / hazard
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Classification
Class I
Status
Ongoing
Distribution / sold at
Worldwide
Recall initiated
2025-09-10
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.
Product quantity
11810 units
Voluntary mandated
Voluntary: Firm initiated
City
Plymouth
State
MN
Country
United States
Event id
97595
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