Q’Apel Recalls Stroke Device After FDA Warning

Q’Apel Medical has recalled its Hippo 072 Aspiration System and Cheetah Delivery Tools—used to remove brain clots—following an FDA warning over safety concerns. The agency flagged unapproved changes to the device's tip, which may cause serious complications like vessel rupture or death.

The recall, affecting 1,617 units, was classified as Class I—the FDA's highest risk level. Linked to two injuries, the device featured a distal nitinol tip not included in Q’Apel’s 2022 regulatory filing. The company opted to discontinue the system instead of pursuing a new approval, citing a strategic shift to newer technologies.

Q’Apel reported three adverse events, including tip detachment and vessel damage, though it claims other factors may have contributed. The case highlights broader regulatory scrutiny, as firms like Abbott and ICU Medical also received FDA warnings for failing to report device changes.

23-06-2025