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

Class I - Dangerous

🏥 Medical Devices Recalled: September 10, 2025 Abbott Surgical Instruments

What Should You Do?

Check if you have this product:
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, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049, 10763071, 10765654, 10780658, 10780710, 10781495, 10781677, 10788527, 10792081, 10792406, 10792407, 10793780, 10799615, 10799616, 10805125, 10805367, 10805369, 10805370, 10805371, 10813353, 10834650, 10844788, 10850740, 10850746, 10851557, 10855920, 10855921, 10868920, 10868921, 10893531, 10978587, 10978588, 11017094, 11017095, 11034753.
Do not eat it: Even if it looks and smells fine, do not consume this product.
Throw it away or return it: You can return the product to the store for a full refund.
Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:: Abbott
Reason for Recall:: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Classification:: Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
Status:: ongoing

Product Information

Full Description:

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

Product Codes/Lot Numbers:

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, 10628998, 10629000, 10638074, 10638488, 10639808, 10641833, 10645657, 10651462, 10651463, 10652440, 10657253, 10696081, 10696560, 10696907, 10705798, 10737121, 10737122, 10737249, 10737251, 10741862, 10742337, 10742342, 10744906, 10748214, 10748215, 10748680, 10749783, 10749788, 10749790, 10763049, 10763071, 10765654, 10780658, 10780710, 10781495, 10781677, 10788527, 10792081, 10792406, 10792407, 10793780, 10799615, 10799616, 10805125, 10805367, 10805369, 10805370, 10805371, 10813353, 10834650, 10844788, 10850740, 10850746, 10851557, 10855920, 10855921, 10868920, 10868921, 10893531, 10978587, 10978588, 11017094, 11017095, 11034753.