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

Hazard

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

Details from the source

Reason for recall: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging. Distribution: Worldwide Quantity: 407 units Lot/code info: 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.

UPC codes

05415067034656

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.