Device for clot removal by Q'Apel is pulled back due to FDA's advisory notice
### Q'Apel Medical Hippo 072 Aspiration System Recalled Due to Safety Concerns
The Food and Drug Administration (FDA) has issued a Class I recall for Q'Apel Medical's Hippo 072 Aspiration System and Cheetah Delivery Tools, following a warning letter from the FDA and the company's submission of three device event reports. This is the FDA’s most serious recall category, indicating a reasonable probability that use of these products could cause serious adverse health consequences or death.
The recall was initiated after regulatory concerns and adverse event reports, though the specific nature of the adverse events has not been detailed in the available sources. Devices are to be removed from where they are used or sold.
Q'Apel has decided to discontinue the recalled system 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 by physicians to remove blood clots in the brain that are blocking blood flow and causing stroke within eight hours of symptoms starting. The devices offer a treatment option for stroke patients who are unable to receive tissue plasminogen activator intravenously or did not respond to the clot-dissolving drug.
The recall affected 1,617 units, as announced by the FDA in April. Using the recalled devices may lead to serious health consequences such as contractions or tears in blood vessels and death.
Several additional significant recalls have been announced recently, including critical devices such as surgical perforators, ventilators, and suction systems, with reasons ranging from sterility issues to mechanical failures and mislabeling.
For the most up-to-date and detailed information, healthcare providers and consumers should consult the FDA’s official medical device recall database. If further information is released about Q'Apel or other manufacturers, it will be posted on the FDA’s website as it becomes available.
Elsewhere, the FDA has sent warning letters to several companies, including Abbott and ICU Medical, for allegedly failing to inform the agency about changes to their medical devices. The agency has also criticized ICU Medical for failing to notify the FDA of updates to infusion pumps.
Abbott was accused of making "multiple significant design changes" to a heart disease test without submitting new premarket notifications. The recall affected 1,617 units, as announced by the FDA in April.
The Recommended Reading Centerline has also recalled a guidewire due to the risk of its coating being left in patients. The Q'Apel Medical company has recalled the Hippo 072 Aspiration System and Cheetah Delivery Tools due to safety concerns raised by the Food and Drug Administration. For more information on these recalls and others, visit the FDA's website.
- The Food and Drug Administration (FDA) has issued a Class I recall for Q'Apel Medical's Hippo 072 Aspiration System and Cheetah Delivery Tools due to safety concerns.
- This is the FDA’s most serious recall category, indicating a reasonable probability that use of these products could cause serious adverse health consequences or death.
- The recall was initiated after regulatory concerns and adverse event reports, though the specific nature of the adverse events has not been detailed in the available sources.
- Q'Apel has decided to discontinue the recalled system as part of its strategic shift toward newer technologies.
- The Hippo 072 Aspiration System is used by physicians to remove blood clots in the brain that are blocking blood flow and causing stroke within eight hours of symptoms starting.
- The FDA has sent warning letters to several companies, including Abbott and ICU Medical, for allegedly failing to inform the agency about changes to their medical devices.
- Using the recalled devices may lead to serious health consequences such as contractions or tears in blood vessels and death.
- For the most up-to-date and detailed information, healthcare providers and consumers should consult the FDA’s official medical device recall database.
