Q’Apel Medical Inc. has initiated a Class I recall of 1,617 units of its 072 Aspiration System (Hippo), according to the FDA. The recall stems from concerns about the distal tip design potentially falling outside the scope of its 510(k) clearance. The product was distributed in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan.
The company has chosen to voluntarily discontinue the 072 Aspiration System line as part of a strategic shift toward newer technologies, rather than pursue a new regulatory pathway. This decision follows a Warning Letter from the FDA that questioned the features and characteristics of the Hippo aspiration catheter's distal tip.
To date, Q’Apel has submitted three Medical Device Reportable events for the Hippo product. These include a reported tip detachment (retrieved without patient injury), a vessel rupture, and a vasospasm. Q’Apel stated that their investigation suggests factors beyond the device’s distal tip likely contributed to the reported adverse events.
The affected product configurations include the 072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing (Catalog Number: APT6072-132), the 072 Aspiration System (Hippo with Cheetah Delivery Tool) (Catalog Number: AP6072-132), and the 072 Aspiration Tubing (Catalog Number: APT-95).
The company has notified customers and distributors to return any available product inventory. Those who have distributed the product to others should contact Q’Apel to facilitate retrieval of remaining stock. For questions or assistance with product return, contact Q’Apel Medical Inc. Customer Service at 510-738-6255 or via email at orders@qapelmedical.com. Health care professionals and patients are encouraged to report adverse events to the FDA's MedWatch program.