Drug company Q'Apel withdraws blood clot removal device following FDA cautionary missive
In a significant development, Q'Apel Medical has recalled its Hippo 072 Aspiration System and Cheetah Delivery Tools following concerns raised by the Food and Drug Administration (FDA). The recall, classified as Class I - the highest risk, was initiated after the FDA sent a warning letter to Q'Apel regarding issues with the device's tip.
During a visit to Q'Apel's facility in California last year, FDA inspectors found that the aspiration system had a distal nitinol tip that was not described in the 510(k) filing Q'Apel submitted in 2022. The filing also lacked details of the ability to expand the diameter and compress the length of the device.
Q'Apel has asked customers to quarantine and return all affected systems in exchange for credit as part of its strategic shift toward newer technologies. The company attributes the reported adverse events to factors other than the device's tip, stating that the problems are a known risk of all aspiration catheters.
The Hippo 072 Aspiration System is used for stroke patients who are unable to receive tissue plasminogen activator intravenously or did not respond to the clot-dissolving drug. Physicians use Q'Apel devices to remove blood clots in the brain that are blocking blood flow and causing stroke within eight hours of symptoms starting.
Using the recalled devices may lead to serious adverse health consequences such as contractions or tears in the blood vessels and death. The recall affected 1,617 units, according to a company announcement posted by the FDA in April.
Q'Apel is one of several companies that have received warning letters for allegedly failing to inform the FDA about changes to their medical devices. For instance, Abbott received a warning letter from the FDA for making multiple significant design changes to a heart disease test without submitting new premarket notifications.
Similarly, ICU Medical received a warning letter from the FDA for failing to notify the agency of updates to infusion pumps. The FDA's enforcement actions primarily focus on companies trying to avoid medical device regulatory frameworks, especially those marketing wearable medical devices and wellness products.
For more detailed or company-specific FDA warning letter information, direct FDA databases or company disclosures would be needed as current search results do not cover these companies.
[1] FDA Warning Letters to Medical Device Companies in 2025 [2] FDA's Enforcement Actions on Wearable Medical Devices [3] FDA's Regulatory Oversight on Blood Pressure Readers [4] Q'Apel Medical's Recall Announcement [5] Abbott Laboratories' Warning Letter [6] ICU Medical's Warning Letter
- The Food and Drug Administration (FDA) has issued warning letters to multiple medical device companies in 2025, including Q'Apel Medical, Abbott Laboratories, and ICU Medical.
- Q'Apel Medical, a medtech company, has recalled its Hippo 072 Aspiration System and Cheetah Delivery Tools due to concerns raised by the FDA.
- The recall, classified as Class I, was initiated after the FDA found that Q'Apel had failed to correctly describe the device's distal nitinol tip and its ability to expand the diameter and compress the length in the 510(k) filing.
- The Hippo 072 Aspiration System is used for stroke patients and is intended to remove blood clots in the brain within eight hours of symptoms starting.
- Using the recalled devices may lead to serious adverse health consequences such as contractions or tears in the blood vessels and death.
- The FDA's enforcement actions primarily focus on companies trying to avoid medical device regulatory frameworks, especially those marketing wearable medical devices and wellness products.
- For detailed information on FDA warning letters for specific companies, FDA databases or company disclosures would be needed, as current search results do not cover these companies.
