FDA Device Recall Z-0109-2026

Abbott · Plymouth, MN

Class I — life-threatening Ongoing

Highest impact — Class I device recall — FDA determination that use of, or exposure to, the device will cause serious adverse health consequences or death.

Device

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

Lot / serial / GTIN: 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, 10960327, 10960343, 10961378, 10962731, 10956836, 10958929, 10984316, 10984788, 10985584, 10987173, 11076153, 10984516, 10985598, 10962737.

Quantity: 407 units

Reason for recall

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

Recall record

Recall number: Z-0109-2026
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Worldwide
Recall initiated: 2025-09-10
Classified by FDA Center: 2025-10-10
FDA published: 2025-10-22
Recalling firm: Abbott
Firm location: Plymouth, MN

Operational response

A Class I device recall indicates a strong likelihood of serious adverse health consequence or death from continued use. Identify affected units by serial number, lot, or GTIN against your inventory and against implanted-device patient registry. Pull affected inventory from active use immediately. For implanted devices, follow the recalling firm’s patient-notification protocol; in most cases this requires informing affected patients and their treating physicians directly.

For the official FDA enforcement record, see FDA's Recall Search.

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