Fremont, CA, United States
Qapel Medical Inc. recalls
1 recall recorded since 2018, most recently on 26 February 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)1
Ongoing Class I Medical devices
- Recall started
- 26 February 2025
- 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.
- Distribution
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1512-2025
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.