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Important Safety Information
The WATCHMAN FLX and WATCHMAN FLX Pro Devices are permanent implants designed to close the left atrial appendage in the heart in an effort to reduce the risk of stroke.
With all medical procedures there are risks associated with the implant procedure and the use of the device. The risks include, but are not limited to, accidental puncture of the heart causing fluid to collect around the heart possibly leading towards the need for an additional procedure, allergic reaction, anesthesia risks, altered mental status or confusion after procedure, arrhythmias (irregular heartbeats), bleeding or throat pain from the TEE (Trans Esophageal Echo) probe, chest pain/discomfort, congestive heart failure, renal failure, excessive bleeding, gastrointestinal bleeding, groin puncture bleed, bruising at the catheter insertion site, groin pain, anemia (reduced red blood cells requiring transfusion), hypotension, infection/pneumonia (example: in or around your heart or lungs), misplacement of the device, improper seal of the appendage or movement of device from appendage wall, clot formation on the device, blood clot or air bubbles in the lungs or other organs, stroke, transient ischemic attack (temporary stroke-like symptoms), cranial bleed (bleeding in or around your brain), thrombosis (blockage of a blood vessel or vein by a clot) and in rare cases death can occur.
Be sure to talk with your doctor so that you thoroughly understand all of the risks and benefits associated with the implantation of the device. SH-2109508-AA