The FDA issued a Class I Recall for the EMBOL-X Glide Protection System, manufactured by Edwards Lifesciences LLC, due to a “deformed cannula tip.” According to the Agency, “[w]hen force is applied to the tip during insertion or removal, it may lead to a separation and embolize.” The recall impacts model numbers EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. All unexpired lot numbers of the EMBOL-X Glide Protection System Cannulae are included in the recall. Read the full safety alert.

Keywords: United States Food and Drug Administration, Medical Device Recalls, Embolization, Therapeutic

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