Q’Apel Medical 072 Aspiration System recall: Distal Tip Design outside scope of 510k clearance

What the company announced

Fremont, CA – April 18, 2025 – On April 7, 2025 , 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.

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 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 product was distributed in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan.

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

Actions to be taken by user:

The Hippo product configurations described above have been discontinued in all markets. 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. If consignees have distributed the product to others, contact Q’Apel so that the company can notify them of this action and retrieve any remaining product.

For questions or assistance with product return, please contact:

Q’Apel Medical Inc. – Customer Service Phone: 510-738-6255

Email: [email protected]

Hours: Monday – Friday, 8:00 a.m. to 5:00 p.m. PT

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online : www.fda.gov/medwatch/report.htm

Regular Mail or Fax : Download form www.fda.gov/MedWatch/getforms.htm or call 1800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

About Q’Apel Medical

Q’Apel Medical is revolutionizing neurovascular interventions. Inspired by the evolving needs of our customers, our novel approach allows us to solve clinical challenges where others fall short. We are up for the task, the more complex the better. Our team thrives on creating high quality uniquely engineered products, designed in partnership with neurovascular specialists, that address what is needed right now, yet with the versatility to focus on what is coming next. For more information, visit www.qapelmedical.com .

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.