The FDA identified the recall of LeMaitre Vascular (NSDQ:LMAT) Over the Wire embolectomy catheters for a failure to deflate as a Class I recall.
Burlington, Mass.–based LeMaitre Vascular’s Over the Wire embolectomy catheter is indicated for use in the surgical removal of blood clots that are lodged in a blood vessel (emboli) and blood clots that form in veins (thrombi). The peripheral vascular disease device maker issued the recall after discovering the risk of the balloon catheter failing to deflate during use.
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