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Aspiration Catheter Recall: Q’Apel Medical, Inc. Removes Hippo 072 Aspiration System and Cheetah Delivery Tool after FDA Warning Letter about Internal Processes and Distal Tip Characteristics

Q’Apel Medical, Inc. is recalling Hippo 072 Aspiration Systems and the Cheetah Delivery Tool after receiving an FDA warning letter that raised concerns about internal processes and the scope of clearance for the Hippo product, as it relates to the distal tip. Specifically, the FDA has raised questions about the features and characteristics of the distal tip of the aspiration catheter when removing a clot during aspiration.

At this time, Q’Apel Medical, Inc. has reported two injuries related to this issue. There have been no reports of death.

This recall involves removing certain devices from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it. 

Questions?

Customers in the U.S. with questions about this recall should contact Q’Apel Medical, Inc. customer service at orders@qapelmedical.com or 510-738-6255.