On November 11, 2009, the US Food And Drug Administration (FDA) issued a Class 1 recall of CardioVations EndoClamp Aortic Catheters, manufactured by Edwards Lifesciences. The device, which is used during some bypass surgeries, has been recalled by the federal government and the biotech company because the catheters have been reported to rupture or burst during heart surgery. The product was manufactured and sold since August of 2008. The model numbers involved in the medical device recall are EC1001 and EC65.

Are the medical devices that your doctor is using on you safe? For time to time, medical devices are found to be defective and recalled by the company that manufactures them. This was the case in December, when eV3 Inc. recalled a TrailBlazer Support Catheter after several health professionals reported cracks in the medical devices. The Food & Drug Administration (FDA) issued a voluntary recall of the 350 defective catheters from 28 different locations in order to prevent any defective medical device incidents or defective medical device injuries.

The Menaflex knee device and the company that makes it, ReGen Biologics Inc. (RGBO), is once again under the scrutiny of the Food & Drug Administration (FDA). An FDA panel has concluded that the medical device company has not offered the government agency enough data to verify that their device is safe for use. The FDA worries that the device may suffer from mechanical failures.

The United States Food & Drug Administration has announced a Class I recall of LIFEPAK 15 monitor/defibrillator. The company that makes the medical device said that the device contains an internal defect that can cause the product to turn off by itself, to turn off and on, or to turn on by itself. This defect could put patients in grave danger.