####072 Aspiration System recalled due to Distal Tip Design outside scope of 510k clearance####, USA

United States

The U.S. Food and Drug Administration ("FDA" or "the agency"), classified Q'Apel Medical, Inc.'s ("Q'Apel" or "the company") voluntary recall of 1,617 units of its 072 Aspiration System (also known under the product name "Hippo", which includes "Cheetah"; collectively, the "product") as Class I. The product was distributed in the United States, Qatar, the United Arab Emirates, and the Republic of Kazakhstan.

On February 26, 2025, the company initiated a discontinuation and recall of 1,617 units of its 072 Aspiration System product. The recall was initiated because the company received a Warning Letter from FDA that raised questions about whether the features and characteristics of the distal tip of the Hippo aspiration catheter were within the scope of its 510(k) clearance. Rather than pursue a new regulatory pathway, the company chose to voluntarily remove all affected product lots and discontinue the 072 Aspiration System line as part of its strategic shift toward newer technologies

Q'Apel has submitted three Medical Device Reportable events for the Hippo product to date; these adverse events 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.

Notably, each of these event types is a known risk associated with the use of any aspiration catheter and is not unique to the Hippo product. The tip of any aspiration catheter used during a thrombectomy could potentially cause vasospasm and/or vascular injury. In particular, if the tip of an aspiration catheter triggers irritation of the vessel wall, it may manifest as vasospasm, which may be self-limiting or may require treatment (e.g., vasodilatation). Vascular injury may result in a non-flow limiting dissection that requires no intervention and causes no permanent morbidity, a flow-limiting dissection that requires intervention and may be associated with morbidity, or in the extreme case, vessel perforation or rupture, which requires intervention and likely results in morbidity or even mortality. If unretrieved, a detached tip of a catheter could result in serious adverse events such as blockage of blood vessels, ischemia of end organs, and death.

The following product configurations have been removed and discontinued:

- 072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing; Catalog Number: APT6072-132; Unique Device Identifier: 00857545008127; Lots: FG241008C-03, FG240916C-04, FG240905C-04

- 072 Aspiration System (Hippo with Cheetah Delivery Tool); Catalog Number: AP6072-132; Unique Device Identifier: 00857545008097; Lots: FG241206A-03, FG240917A-01

- 072 Aspiration Tubing; Catalog Number: APT-95; Unique Device Identifier: 00857545008103; Lot: FG241206A-04

The company has proactively notified all customers and distributors and will continue to monitor the situation closely. Consignees of the product should immediately return any available product inventory to the company.