WASHINGTON, D.C. — The medical device manufacturer Applied Medical announced that it would recall three of its catheters due to the separation of components while in use. The U.S. Food and Drug Administration (FDA) considers Applied Medical’s recall to require a Class I designation. The FDA’s Class I designation means that continued use of the recalled medical device could kill the patient or cause a severe injury. According to the FDA, if the catheter tip breaks off, further surgery could be required to remove it from the patient. Worse still, the dislodged tip could damage a blood vessel, leading to complications up to and including death.
Applied Medical announced its recall for the Python Embolectomy Catheter, OWT Latis Cleaning Catheter, and its Bard Embolectomy Catheter. The devices use latex balloons to temporarily block a blood vessel, close off a blood vessel, or to infuse fluids. The company recalled these three catheters because the catheter tip could break free during insertion or while inside of the patient. If that happens, the patient will have pieces of a broken catheter in the blood vessels that could progress toward the heart and lungs, and could eventually kill the patient.
The FDA has received three medical device reports about Applied Medical’s three recalled catheters. Overall, Applied Medical has received 46 complaints about its recalled devices since 2015. Neither Applied Medical nor the FDA reported any deaths or injuries. However, both entities recognize that urgent need to recall the devices because of the tremendous risk a patient could die from a blocked blood vessel or could sustain severe damage during any surgical procedure to remove the broken tip.
Applied Medical sent an urgent recall letter to all of its catheter customers with specific information to identify the recalled devices.
MedTechDive.com reported that this recall is the second recall for catheters within the last month due to tips breaking and potentially becoming lodged in the patient’s body.
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