St. Jude Medical is recalling 483 units of the TactiFlex Ablation Sensor Enabled Ablation Catheter (Model A-TFSE-FJ) because the EnSiteX EP mapping system may misidentify them as a different product model. This error causes specific catheter features to disappear from the medical display and may cause the catheter's image to appear upside down or inverted during heart procedures. Healthcare providers should be aware that these display issues could affect the accuracy of visual information during cardiac treatments. The recall involves nine specific lot numbers distributed across the United States and Canada with expiration dates in late 2024.
When the mapping system misidentifies the catheter, it fails to show critical safety or performance features and may display an inverted image, which could lead to procedural delays or clinical errors during sensitive cardiac ablation procedures.
Manufacturer notification and technical guidance
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.
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Sources: FDA iRES · Raw API Response
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