Recall Z-1512-2025— Qapel Medical Inc.

Name: FDA recall Z-1512-2025
Creator: U.S. Food and Drug Administration
Published: 2025-02-26

Class I · Ongoing

Class I FDA medical device recall by Qapel Medical Inc., initiated 2025-02-26. It names one FDA 510(k) clearance: K222786. Product: 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. 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..

Recalling firm: Qapel Medical Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-02-26
Firm location: Fremont, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K222786 — 072 Aspiration SystemQ'Apel Medical, Inc.·cleared 2023-08-25

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.