Cook Medical has reintroduced its Evolution RL and Evolution Shortie RL controlled-rotation dilator sheath sets in the US market, effective immediately, the company said Thursday.

Distribution of the sheaths was suspended for two months while Cook worked with the FDA to resolve questions about the products’ marketing clearance.

The temporary withdrawal followed an April 15 FDA warning letter that cited promotional material on the company’s website indicating that the Cook Evolution Mechanical Dilator Sheath Set had undergone design modifications since its original clearance.

The changes included “what appears to be an extension to the Evolution line and material changes to the sheath,” the letter said. The device is cleared for use in the percutaneous dilation of tissue surrounding cardiac leads, indwelling catheters and foreign objects.

The devices remained available in Europe and other markets. — Kellen Owings

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