Company discontinues device amid regulatory and safety concerns
Q’Apel Medical’s recall of its 072 Aspiration System—marketed as the “Hippo” and including the “Cheetah” component—has been classified by the FDA as a Class I recall, indicating potential for serious injury or death.
The recall affects 1,617 units following an FDA warning letter questioning whether the device’s distal tip features aligned with its 510(k) clearance. Instead of pursuing additional regulatory clearance, Q’Apel opted to fully discontinue the system.
Three adverse events have been reported:
- One tip detachment (retrieved without injury)
- One vessel rupture
- One vasospasm
Q’Apel attributes these incidents to procedural factors rather than the device itself, though it acknowledges these are known risks for any aspiration catheter. The recall affects distributions in the U.S., Qatar, UAE, and Kazakhstan.
The move is part of a broader shift in Q’Apel’s strategy toward next-generation neurovascular technologies.
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