Z-1512-2025 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 16, 2025
- Initiation Date
- February 26, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1617
Product Description
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
Reason for Recall
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
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
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)