Abbott is recalling approximately 103,384 TactiFlex Sensor Enabled Ablation Catheters due to reports of the catheter tip detaching while being removed from its packaging. If a tip detaches and is not noticed before a procedure, it could lead to serious medical complications or the need for additional surgery. This recall involves several models of the 8F, 115 cm cardiac catheters with various curve types (D, DD, DF, FJ, and F).
The catheter tip may break off or detach from the device during the initial removal from the packaging. If the device is then used in a patient, the detached tip could cause blood clots, damage to blood vessels, or embolisms within the heart or vascular system.
Quantity affected: 407 units
Quantity affected: 3404 units
Quantity affected: 85803 units
Quantity affected: 11810 units
Quantity affected: 1960 units
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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