Recall Z-1512-2025 ยท NRY Catheter, Thrombus Retriever
Qapel Medical Inc.
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
| Date | Apr 7, 2025 (initiated Feb 26, 2025) |
| Status | Open, Classified |
| 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222786 | 072 Aspiration System Q'Apel Medical, Inc., Aug 25, 2023 |