Device product
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery Tool, REF: AP6072-132. 072 Aspiration Tubing, REF: APT-95
Z-1512-2025
Product summary
- Event
- Event 96492
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 1617
- Official record key
device-enforcement:Z-1512-2025
Official wording
Reason: Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
Code information: REF/UDI-DI/Lot(Expiration): APT6072-132/00857545008127/FG241008C-03(04/07/2025), FG240916C-04(03/17/2025), FG240905C-04(03/06/2025). AP6072-132/00857545008097/FG241206A-03(06/08/2025), FG240917A-01(03/17/2025). APT-95/00857545008103/FG241206A-04(06/08/25)
Distribution pattern: US: CA, IL, NE, TN, TX, NJ, NC, SD, FL, MI, PA, GA, AL, IN, NY, WI, AZ, MN, LA, OH, OK, SC, NV, ND, ID, MO, CT, WA, MA. OUS: QATAR, United Arab Emirates, Republic of Kazakhstan
Derived failure modes
-
Unknown
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.