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
FDA Recall Z-1512-2025 · Posted 2025-04-07
Advertisement
Recalling FirmQapel Medical Inc.
Recall StatusOpen, Classified
Product CodeNRY
Date Initiated2025-02-26
Product Quantity1617
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.
Firm 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 [email protected]
If you have any questions regarding this letter, please contact customer service for further information at [email protected], or by phone at 510-738-6255 between the hours of 8am - 5pm PST.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement