The Food and Drug Administration (FDA) is reporting on a recall of Cook Medical fixed core wire guides due to a manufacturing error.
The Cook Medical fixed core wire guide is a curved wire made of stainless steel with non-reactive coating. The device helps insert and guide the placement of medical devices and introducer sheaths inside a patient’s body. The manufacturer reports that 5 lots of wire guides dropped onto an unchecked surface during production. This drop could cause the wire guide to bend out of shape or become dirty.
The FDA has identified this recall as a Class I recall; use of these devices may cause serious injuries or death. There have been no complaints about this device issue. There have been no reported injuries or deaths.
Food and Drug Administration (FDA). Cook Medical Recalls Fixed Core Wire Guides, Due to Device Damage from a Manufacturing Error [news release]. November 12, 2020. Available at: click here. Accessed November 16, 2020.