 
The U.S. Food and Drug Administration (FDA) is aware that Abbott has issued a letter to affected customers recommending updated instructions when removing the TactiFlex Ablation Catheter, Sensor Enabled from its packaging due to reports of tip detachment.
Tip detachment is most often detectable prior to use, and, if a tip detaches prior to insertion into the patient, the physician should replace the catheter. In the event the tip detaches during the procedure, there is the potential for embolism or migration of the detached material. This can potentially lead to respiratory compromise, hemodynamic instability, stroke, ischemia, cardiac perforation, and/or vascular injury.
As of September 11, Abbott has not reported any serious injuries or deaths associated with this issue.
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program. The FDA has become aware of a potentially high-risk issue. The FDA will keep the public informed and update this web page as significant new information becomes available.
Questions?
Customers in the U.S. with adverse reactions, quality problems, or questions about this recall should contact Abbott at 1-855-478-5833.
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