FREMONT, Calif., April 18, 2025 /PRNewswire/ -- On April 7, 2025, the U.S. Food and Drug Administration (FDA) classified the voluntary recall initiated by Q'Apel Medical, Inc. for 1,617 units of its 072 Aspiration Systemalso known by its product name, "Hippo"as a Class I recall. This classification is significant because it indicates that the recalled products may pose a reasonable probability of causing serious adverse health consequences or death.

The recall was first announced on February 26, 2025, when Q'Apel took decisive action to discontinue the 072 Aspiration System following a Warning Letter from the FDA. This letter raised serious concerns about the compliance of the distal tip of the Hippo aspiration catheter with the scope of its 510(k) clearance. Faced with regulatory challenges and the potential for further complications, the company opted for a voluntary product removal instead of pursuing a new regulatory pathway. This strategic decision reflects Q'Apels commitment to patient safety and innovation, as they pivot towards developing newer technologies.

To date, Q'Apel has reported three Medical Device Reportable events concerning the Hippo product. Among these incidents were a tip detachment, which was retrieved without causing injury to the patient, a vessel rupture, and a vasospasm. Although these adverse events raise concerns, the investigation suggests that factors beyond the distal tip of the device likely contributed to these incidents. It is important to note that such adverse events are recognized risks associated with the use of any aspiration catheter and are not exclusive to the Hippo product.

The potential risks associated with aspiration catheters can include vasospasms and vascular injuries, which may occur if the catheter tip irritates the vessel wall. Such reactions could be self-limiting or necessitate medical intervention, such as vasodilatation. In severe cases, vascular injury may lead to complications ranging from non-flow limiting dissections, which require no intervention, to flow-limiting dissections that warrant medical intervention, and in the most extreme scenarios, vessel perforations or ruptures that pose severe health risks.

The distribution of the affected product was not limited to the United States; it also reached international markets including Qatar, the United Arab Emirates, and the Republic of Kazakhstan. Customers in these regions have also been advised to discontinue the use of the product.

The specific configurations of the 072 Aspiration System that have been recalled include the following:

  • 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

In light of these developments, Q'Apel is taking proactive measures to ensure the safety of its customers. The company has already notified all customers and distributors regarding the discontinuation of the affected product lines. Users are urged to return any remaining inventory of the recalled products to Q'Apel promptly. If the product has been distributed to other entities, recipients are advised to contact Q'Apel to facilitate the notification and retrieval process.

For any questions or assistance regarding product returns, customers can reach out to Q'Apel Medical Inc. Customer Service:

Phone: 510-738-6255
Email: info@qapelmedical.com
Hours: Monday Friday, 8:00 a.m. to 5:00 p.m. PT

Adverse reactions or quality issues related to the use of these products can be reported to the FDAs MedWatch Adverse Event Reporting program. Reports can be submitted online, by regular mail, or via fax.

For more information and to report adverse events, visit