FDA WARNING_LETTER - Cook Vascular Inc.

The FDA issued a Warning Letter to Cook Vascular, Inc. regarding the Cook Evolution RL and Shortie RL Bi-directional Dilator Sheath Sets. The FDA determined these devices are being marketed in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

Specifically, the devices are adulterated under section 501(f)(1)(B) because Cook Vascular lacks an approved premarket approval (PMA) or investigational device exemption (IDE). They are also misbranded under section 502(o) because major changes or modifications to the intended use were made without submitting a new premarket notification (510(k)).

The original Cook Evolution Mechanical Dilator Sheath Set (K061000) was cleared for percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters, and foreign objects. However, promotional materials show design changes, including an extension to the Evolution line, material changes, a birotational sheath with a mechanism for changing direction, a decagon-shaped tip, and larger sizes (11.0 and 13.0 FR) compared to the original 7.0 and 9.0 FR. A new device system, the Evolution Shortie RL Dilator Sheath Set, designed for vessel entry, also appears to be marketed without clearance.

Cook Vascular is required to immediately cease activities resulting in misbranding or adulteration and take prompt corrective