Hippo 072 Aspiration System (Qapel) – Catheter Tip Defect (2025)

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.

Recommended Action

Per FDA guidance

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.

Distribution

As reported by FDA

AL, AZ, CA, CT, FL, GA, ID, IL, IN, LA, MA, MI, MN, MO, NE, NV, NJ, NY, NC, ND, OH, OK, PA, SC, SD, TN, TX, WA, WI