The U.S. Food and Drug Administration (FDA) has classified a recall by Q’Apel Medical, Inc., of its 072 Aspiration System, also known as Hippo, as a Class I recall. The recall, initiated on February 26, involved 1,617 units of the Hippo system, including the Cheetah version. The Fremont-based company decided to cease the product line after receiving an FDA Warning Letter questioning the catheter's compliance with its 510(k) clearance. Instead of pursuing a new regulatory pathway, Q’Apel opted for a strategic move toward newer technologies.
The company has reported three adverse events related to the Hippo product, including a detachable tip that was retrieved without patient harm, a vessel rupture, and a vasospasm. Q’Apel's investigations suggest that factors beyond the device's design may have contributed to these events.
The company has highlighted that these risks, such as vasospasm and vascular injury, are not uncommon with any aspiration catheter.
Distribution of the product occurred in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan. Specific product configurations affected by the recall include multiple lot numbers of the 072 Aspiration System and its tubing.
Users are urged to return any remaining inventory and to notify Q’Apel if further distribution of the product has occurred. Questions about returns can be directed to Q’Apel Medical’s customer service. Furthermore, any adverse reactions experienced with the product should be reported to the FDA's MedWatch program.
Q’Apel Medical describes its commitment to addressing clinical challenges in neurovascular interventions through innovative product development.
