[pending] Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132.
Pending LLM rewrite. Source: FDA_DEVICE Z-1512-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
The recalled product
- 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
- Manufacturer
- Qapel Medical Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- 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
Distributed in 29 states:
- 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
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