FDA Device recall Z-1512-2025
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132
- FDA Device
- Class I
- ongoing
- Published 2025-04-16
On 2025-04-16 the FDA classified a Class I recall of Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132 by Qapel Medical, citing aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1512-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-02-26 |
| Published | 2025-04-16 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Qapel Medical |
| Distribution | AL, AZ, CA, CT, FL, GA, ID, IL, IN, LA, MA, MI, MN, MO, NC, ND, NE, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, WA, WI |
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
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.
Identifiers
| code_info | REF/UDI-DI/Lot(Expiration): APT6072-132/00857545008127/FG241008C-03(04/07/2025), FG240916C-04(03/17/2025), FG240905C-04…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) |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1512-2025%22
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