#United States #Fremont #Q'Apel Medical #Aspiration System #FDA Recall

FDA Classifies Q'Apel Medical's 072 Aspiration System Recall

On April 7, 2025, the U.S. Food and Drug Administration (FDA) declared a Class I recall for the 072 Aspiration System, commonly known as the Hippo, by Q'Apel Medical, Inc., due to significant safety concerns linked to the device. This classification indicates a potential for serious harm or death associated with the product’s use.

The decision to recall came after Q'Apel Medical voluntarily initiated a withdrawal of 1,617 units of the 072 Aspiration System on February 26, 2025, prompted by a Warning Letter from the FDA. The letter raised concerns regarding whether the distal tip of the Hippo aspiration catheter was compliant with the standards established under its 510(k) clearance. Rather than navigate a new regulatory pathway, the company opted for a complete removal and discontinuation of the product line as part of a strategic pivot towards new and improved technologies.

The recall covers specific configurations of the 072 Aspiration System, including the Hippo with Cheetah Delivery Tool and its associated aspiration tubing. Affected product catalog numbers include APT6072-132 and AP6072-132, spanning multiple lot numbers. Q'Apel has proactively reached out to all customers and distributors, enabling a timely return of the inventory.

According to Q'Apel's reports, there have been three recorded Medical Device Reportable events associated with the Hippo device. These involved an incident where the tip of the catheter detached, retrieved without causing harm to the patient, as well as cases of vessel rupture and vasospasm. Notably, the company attributes these adverse events to factors beyond just the device's distal tip, emphasizing that such issues can arise with any aspiration catheter, a state-of-affairs well understood in the medical community.

The risk of adverse outcomes, such as vasospasm and vascular injury, stems from the nature of aspiration catheters used during thrombectomy procedures. If a catheter tip irritates the vessel wall, it can lead to vasospasm, which may resolve uneventfully or require treatment. More serious complications resulting from vascular injury may involve dissection that could require intervention, or in severe cases, may lead to vessel perforation or rupture.

In terms of geographical distribution, the product was sold not only across the United States but also in international markets including Qatar, the United Arab Emirates, and Kazakhstan. This expansive recall necessitates meticulous monitoring and responsive actions by Q'Apel Medical to ensure customer safety and compliance.

For users and healthcare providers with inventory of the affected units, immediate returns to Q'Apel are encouraged. Q'Apel’s customer service team is available to assist with the returns process via phone or email. Patients and healthcare practitioners are advised to report any adverse reactions or issues related to the Hippo product directly to the FDA’s MedWatch Adverse Event Reporting program, available online or through traditional mail.

About Q'Apel Medical

Q'Apel Medical specializes in innovative solutions for neurovascular interventions, striving to meet the clinical challenges faced by healthcare professionals today. Their products are designed collaboratively with neurovascular specialists, ensuring high standards and adaptability for future medical needs.

For more information about their products or to seek help regarding the recall, visit Q'Apel Medical.