Aspiration system for stroke thrombectomy recalled, discontinued after FDA raises concerns
Q’Apel Medical is recalling its 072 Aspiration System after receiving a warning letter from the U.S. Food and Drug Administration (FDA). The company is also discontinuing the device and focusing on newer technologies going forward.
The FDA has ruled that this is a Class I recall, meaning the use of this device may result in serious injuries or death.
The 072 Aspiration System includes a “Hippo” aspiration catheter and “Cheetah” guiding system designed to remove blood clots in patients with large vessel occlusion (LVO) acute ischemic strokes. The FDA sent a warning letter Q’Apel Medical that “raised questions” about different features and characteristics associated with the distal tip of the Hippo aspiration catheter. As a response to that warning, the company chose to voluntarily remove the devices from market and move on completely.
According to Q’Apel Medical, three adverse events related to this device have been reported to the FDA. This included a tip detachment, which the company said was corrected without injuring the patient, as well as 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,” Q’Apel Medical said in an advisory on the FDA website.
These interventional devices have been distributed in the United States, Qatar, United Arab Emirates and the Republic of Kazakhstan. All customers and distributors have been previously notified, and Q’Apel Medical has said it will “continue to monitor the situation closely.”
“Consignees of the product should immediately return any available product inventory to the company,” the company said. “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.”
A total of 1,617 lots of the devices are included in this recall. Read the full advisory for additional details.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.