The company earlier this year initiated a discontinuation and recall of the system, also known as “Hippo,” which includes “Cheetah.” It recalled 1,617 units of the Hippo system after receiving an FDA warning letter. The letter questioned if features and characteristics of the Hippo aspiration catheter’s distal tips landed within the scope of its 510(k) clearance.
Rather than pursue a new regulatory pathway, Q’Apel chose to remove all affected products and discontinue the system. It says this comes as part of a strategic shift toward newer technologies.
To date, Q’Apel reports three medical device reportable events for Hippo. These adverse events included a reported tip detachment, retrieved without patient injury, a vessel rupture and a vasospasm. Based on an investigation, the company says factors other than the device’s distal tip likely contributed to the reported adverse events. The company says each event type is a known risk associated iwth the use of any aspiration catheter.
Despite this, Q’Apel still elected to pull the device from its distribution areas in the U.S., Qatar, United Arab Emirates and the Republic of Kazakhstan.
Q’Apel removed and discontinued the following product configurations:
- 072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing; Catalog Number: APT6072-132; Unique Device Identifier: 00857545008127; Lots: FG241008C-03, FG240916C-04, FG240905C-04
- 072 Aspiration System (Hippo with Cheetah Delivery Tool); Catalog Number: AP6072-132; Unique Device Identifier: 00857545008097; Lots: FG241206A-03, FG240917A-01
- 072 Aspiration Tubing; Catalog Number: APT-95; Unique Device Identifier: 00857545008103; Lot: FG241206A-04
