Qapel Medical Inc.: Device Recall
Recall #Z-1512-2025 · 02/26/2025
Class I: Dangerous
Recall Details
- Recall Number
- Z-1512-2025
- Classification
- Class I
- Product Type
- Device
- Recalling Firm
- Qapel Medical Inc.
- Status
- Ongoing
- Date Initiated
- 02/26/2025
- Location
- Fremont, CA, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1617
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.
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
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
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.