FDA Medical devices recall ·
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0112-2026
- Date
- (initiated September 10, 2025)
- Company / brand
- Abbott
5050 Nathan Ln N, Plymouth, MN, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 11810 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
TactiFlex Sensor Enabled Ablation Catheter, 8F, 115 cm, FJ, (BiD Curve F-J), REF A-TFSE-FJ; cardiac catheter
Why was it recalled?
Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 1076
Distribution
Worldwide
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-0112-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.