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.
Affected Products
- Product Names: 072 Aspiration System or Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing
| Product Description | Unique Device Identifier | Manufacturer’s Product Catalog Number | Lot Number | Expiration Date (MM/DD/YYYY) |
|---|---|---|---|---|
| 072 Aspiration System with Aspiration Tubing | 00857545008127 | APT6072-132 | FG241008C-03 | 04/07/2025 |
| FG240916C-04 | 03/17/2025 | |||
| FG240905C-04 | 03/06/2025 | |||
| 072 Aspiration System | 00857545008097 | AP6072-132 | FG241206A-03 | 06/08/2025 |
| FG240917A-01 | 03/17/2025 | |||
| 072 Aspiration Tubing | 00857545008103 | APT-95 | FG241206A-04 | 06/08/2025 |
What to Do
On February 26, 2025, Q’Apel Medical, Inc. sent all affected customers a Voluntary Medical Device Removal and Discontinuation letter recommending the following actions:
- Quarantine any remaining Hippo 072 Aspiration Systems.
- Return all remaining systems to Q’Apel Medical, Inc. to receive credit.
- Do not destroy devices.
- Let Q’Apel Medical, Inc. know if the product was transferred to others so they can be notified and systems can be retrieved.
- Complete the customer Acknowledgement and Response Card included with the letter to make sure Q’Apel has accounted for all devices.
- Once the Acknowledgement and Response Card is completed, Q’Apel Medical, Inc. will provide a Returned Material Authorization (RMA) number and shipping or pick up instructions.
Reason for Recall
Q’Apel Medical, Inc. is recalling Hippo 072 Aspiration Systems 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.
The use of affected product may cause serious adverse health consequences, including contractions (vasospasm) or tears (rupture) in the blood vessels, and death.
At this time, Q’Apel Medical, Inc. has reported two injuries related to this issue. There have been no reports of death.
Device Use
The Hippo 072 Aspiration System is indicated for use to remove blood clots in the brain that are blocking blood flow and causing stroke within 8 hours of symptom onset. Patients who are not able to receive a treatment called tissue plasminogen activator (t-PA) through the blood vessels (intravenously, or by IV) or whose clots did not respond to IV t-PA therapy are candidates for treatment with this device.
Contact Information
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.
Additional FDA Resources:
Additional Company Resources:
Unique Device Identifier (UDI)
The unique device identifier (UDI) helps identify individual medical devices sold in the United States from distribution to use. The UDI allows for more accurate reporting, reviewing, and analyzing of adverse event reports so that devices can be identified more quickly, and as a result, problems potentially resolved more quickly.
How do I report a problem?
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.
