Abbott: Medical Device Recall in 2025 - (Recall #: Z-0113-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class I

Date Initiated: September 10, 2025

Date Posted: October 22, 2025

Recall Number: Z-0113-2026

Event ID: 97595

Reason for Recall:

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

Status: Ongoing

Product Quantity: 1960 units

Code Information:

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.

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated