Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiratio
FDA device recall Z-1512-2025 · posted 2025-04-07 · Open, Classified
Recall details
- Recalling firm
- Qapel Medical Inc.
- 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.
- Action taken
- On 2/26/2025, removal and discontinuation notices were mailed to customers were asked to do the following: 1) Quarantine affected devices and return to the firm. 2) If you have provided this product to others, let the firm know so they can notify them of this action and retrieve any remaining product. 3) Complete and return the Acknowledgement and Response Card via email to orders@qapelmedical.com If you have any questions regarding this letter, please contact customer service for further information at orders@qapelmedical.com, or by phone at 510-738-6255 between the hours of 8am - 5pm PST.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- NRY
- Quantity affected
- 1617
- 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
- Date initiated
- 2025-02-26
- Date posted
- 2025-04-07
- Location
- Fremont, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 072 Aspiration System (K222786) | Q'Apel Medical, Inc. | 2023-08-25 |