Hippo 072 Aspiration System including Cheetah Delivery Tool and… — Class I medical device recall Z-1512-2025
Ongoing recall by Qapel Medical Inc., reported 2025-04-16, distributed in AL, AZ, CA, CT, FL, GA, ID, IL…. Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip deta
| Recall number | Z-1512-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Qapel Medical Inc., Fremont, CA, United States |
| Recall initiated | 2025-02-26 |
| Classified | 2025-04-07 |
| Reported by FDA | 2025-04-16 |
| Distributed | 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 |
| Countries outside the US | AE, QA |
| Quantity | 1,617 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00857545008097, 00857545008103, 00857545008127 |
| Model numbers | 072, AP6072-132, APT-95, APT6072-132 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1512-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.