Following an FDA Warning Letter citing the firm for failing to update the 510(k) clearance for its Evolution RL and Evolution Shortie RL lead extraction systems, Cook Medical (Bloomington, IN) has pulled the devices from the US market. The Warning Letter says that Cook was selling “this device with major changes or modifications to the intended use without submitting a new premarket notification to FDA.” The Evolution RL Controlled-Rotation Dilator Sheath Set, which originally received approval in 2006, and the Evolution Shortie RL Controlled-Rotation Dilator Sheath Set are intended for “use in patients requiring the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects,” according to Cook’s website.
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