Abbott medical device recall: TactiFlex Sensor Enabled Ablation Catheter

Reason for recall

Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.

What the classification means

• Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.

About this recall

The firm started this recall on Sep 10, 2025. FDA classified it 30 days later, on Oct 10, 2025. This recall event covers 5 separate products, each with its own FDA recall number. Distribution reported by FDA: Worldwide Abbott has 14 recalls in our records.

Recalled products (5)

• Z-0109-2026 Class I Ongoing

  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, D, (UniD Curve D), REF A-TFSE-D; cardiac catheter

  Codes / lots: GTIN 05415067034656, Batch Numbers: 8894231, 8915981, 9029640, 9255006, 10001631, 10053399, 10103653, 10120408, 10151069, 10194386, 10194388, 10217380, 10389653, 10429584, 10440518, 10513213, 10513225, 10513232, 10513235, 10551326, 10562041, 10562047, 10562049, 10566077, 10597231, 10597242, 10597249, 10597260, 10613572, 10613581, 10613583, 10613585, 10632079, 10632621, 10632626, 10632634, 10646249, 10673011, 10675350, 10676858, 10677749, 10680007, 10757210, 10785266, 10798695, 10798697, 10816723, 10817847, 10817849, 10850906, 10850907, 10858157, 10858160, 10860077, 10871703, 10885761, 10885921, 10889919, 10892126, 10896652, 10898353, 10899933, 10900171, 10903297, 10903302, 10909596, 10910449, 10910454, 10913639, 10914972, 10917505, 10918937, 10922625, 10922639, 10928017, 10938688, 10939318, 10939319, 10939322, 10950790, 10954012, 10954308, 10954309, 10956216, 10956223, 10957148,…

  Quantity: 407 units

• Z-0110-2026 Class I Ongoing

  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DD, (BiD Curve D-D), REF A-TFSE-DD; cardiac catheter

  Codes / lots: GTIN 05415067034557, Batch Numbers: 8843948, 8855039, 8906316, 8913730, 8921154, 8922146, 8933195, 8947323, 8949324, 8958968, 8959452, 8960986, 8961409, 8963254, 8965484, 8965486, 8991236, 8993365, 9001917, 9003044, 9003047, 9012222, 9013428, 9015293, 9038354, 9039239, 9065946, 9066884, 9071294, 9119487, 9138236, 9147733, 9148411, 9156153, 9158891, 10162247, 10173398, 10205310, 10207502, 10218030, 10228449, 10228450, 10230429, 10232940, 10235434, 10235436, 10240235, 10242138, 10242992, 10242995, 10280672, 10288053, 10288057, 10289553, 10289668, 10289709, 10289759, 10297899, 10334695, 10334845, 10338853, 10338856, 10343551, 10360411, 10375524, 10382430, 10384530, 10384531, 10395601, 10395605, 10449220, 10451314, 10451768, 10451769, 10458698, 10465076, 10465083, 10465086, 10466761, 10469707, 10509213, 10565373, 10565827, 10566663, 10599493, 10600697, 10601488, 10610624, 10615028,…

  Quantity: 3404 units

• Z-0111-2026 Class I Ongoing

  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, DF, (BiD Curve D-F), REF A-TFSE-DF; cardiac catheter

  Codes / lots: GTIN 05415067034571, Batch Numbers: 8707463, 8728375, 8848814, 8849428, 8856153, 8859777, 8930724, 8948407, 9085267, 9134878, 9139151, 9151701, 9154571, 9170156, 9172378, 9202684, 10005870, 10014420, 10014422, 10035838, 10060049, 10067495, 10074488, 10093061, 10095119, 10133240, 10143719, 10146336, 10150246, 10150248, 10158750, 10163256, 10168649, 10175479, 10191672, 10206135, 10219459, 10246287, 10250075, 10259721, 10266993, 10268128, 10278549, 10278947, 10278998, 10279023, 10279962, 10282364, 10284613, 10286135, 10299761, 10301720, 10301724, 10302971, 10310965, 10313193, 10321650, 10321684, 10330213, 10334312, 10337388, 10343800, 10346421, 10347095, 10350600, 10356054, 10356057, 10358260, 10358261, 10358263, 10358912, 10359408, 10359726, 10364782, 10368136, 10369950, 10373269, 10383386, 10392552, 10398359, 10399262, 10399266, 10401107, 10401352, 10405601, 10406221, 10413503, 10419427,…

  Quantity: 85803 units

• Z-0112-2026 Class I Ongoing

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

  Codes / lots: 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,…

  Quantity: 11810 units

• Z-0113-2026 Class I Ongoing

  TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, F, (UniD Curve F), REF A-TFSE-F; cardiac catheter

  Codes / lots: GTIN 05415067034670, Batch Numbers: 8894357, 8917490, 8984945, 10061309, 10061314, 10061316, 10061317, 10084510, 10084518, 10089968, 10089971, 10099711, 10132013, 10132015, 10132017, 10217367, 10360478, 10360488, 10371567, 10371569, 10371577, 10399929, 10418884, 10418885, 10418895, 10429561, 10429563, 10479188, 10479190, 10482343, 10482351, 10482363, 10482378, 10513080, 10533833, 10533851, 10533854, 10566078, 10597230, 10646250, 10646251, 10646253, 10673213, 10673240, 10684728, 10684732, 10684739, 10684740, 10688513, 10692386, 10695444, 10705803, 10710366, 10713073, 10758992, 10792240, 10792924, 10803221, 10803222, 10812417, 10812431, 10830792, 10830798, 10835329, 10835331, 10861887, 10866457, 10868070, 10870874, 10872753, 10878395, 10878673, 10879391, 10879406, 10978688, 10978690.

  Quantity: 1960 units