FDA Medical devices recall ·
Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-1512-2025
- Date
- (initiated February 26, 2025)
- Company / brand
- Qapel Medical Inc.
4245 Technology Dr, Fremont, CA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1617
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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)
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
States: Alabama Arizona California Connecticut Florida Georgia Idaho Illinois Indiana Louisiana Massachusetts Michigan Minnesota Missouri North Carolina North Dakota Nebraska New Jersey Nevada New York Ohio Oklahoma Pennsylvania South Carolina South Dakota Tennessee Texas Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-1512-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.