Q’Apel Recalls Aspitration System

Q’Apel Medical is recalling (Class 1) and discontinuing the marketing of its 072 Aspiration System (also known under the product name “Hippo” and “Cheetah”) based on a recent Warning Letter that raised questions about whether the features and characteristics of the catheter’s distal tip were within the scope of its 510(k) clearance. Rather than pursue a new regulatory pathway, the company chose to recall all affected product lots and discontinue the device line as part of its strategic shift toward newer technologies, according to a recall notice.

Q’Apel says it has filed three Medical Device Reporting events for the Hippo product that include a reported tip detachment, retrieved without patient injury; a vessel rupture; and a vasospasm. “Based on the company’s investigation of these events, factors other than the device’s distal tip likely contributed to the reported adverse events,” the notice says.