Dive Brief:
- Q’Apel Medical has recalled a device for removing blood clots in the brain over an issue linked to two injuries, the Food and Drug Administration said Tuesday.
- The company asked customers to return Hippo 072 Aspiration Systems and Cheetah Delivery Tools after receiving a warning letter in which the FDA raised concerns about the device’s tip.
- Using the recalled devices may have serious adverse health consequences including contractions or tears in the blood vessels and death, the FDA said.
Dive Insight:
Physicians use the Q’Apel devices 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 way to treat stroke patients who are either unable to receive tissue plasminogen activator intravenously or did not respond to the clot-dissolving drug.
FDA inspectors visited Q’Apel’s facility in California last year. The inspection found the aspiration system had a distal nitinol tip that was not described in the 510(k) filing Q’Apel submitted in 2022. Specifically, the filing lacked details of the ability to expand the diameter and compress the length of the device.
Q’Apel recalled the device in February, three weeks after the FDA sent the warning letter. The company asked customers to quarantine and return all affected systems in exchange for credit. The recall affected 1,617 units according to a company announcement posted by the FDA in April.
The FDA categorized the recall earlier that month as Class I, the highest risk, according to the announcement. Q’Apel said that rather than “pursue a new regulatory pathway,” it was discontinuing the recalled system “as part of its strategic shift toward newer technologies.”
At that time, Q’Apel had submitted three medical device reportable events for the system. The reports described a tip detachment, a vessel rupture and a vessel contraction. Q’Apel said factors other than the device’s tip likely contributed to the reported adverse events, adding that the problems are a known risk of all aspiration catheters.
Q’Apel is one of several companies that have received warning letters for allegedly failing to tell the FDA about changes to their medical devices. The FDA sent warning letters to Abbott for making “multiple significant design changes” to a heart disease test without submitting new premarket notifications and ICU Medical for failing to notify the agency of updates to infusion pumps.
