Z-1512-2025Class I

Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo...

Name: Z-1512-2025 Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo...
Creator: Qapel Medical Inc.
Published: 2025-02-26
License: https://open.fda.gov/license/

Q'apel Medical, Inc. / initiated 2025-02-26 / Open, Classified / root cause: design

FDA source

Qapel Medical Inc. began a recall of Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, REF: APT6072-132. Hippo 072 Aspiration System including Cheetah Delivery... on 2025-02-26. FDA classified it as Class I and gives the reason as "Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-1512-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-26
Posted: 2025-04-07
Recalling firm: Q'apel Medical, Inc.
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
Product code: NRY Catheter, Thrombus Retriever
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 1617
Distribution: 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
Product codes and lots: REF/UDI-DI/Lot(Expiration): APT6072-132/00857545008127/FG241008C-03(04/07/2025), FG240916C-04(03/17/2025), FG240905C-04(03/06/2025). AP6072-132/00857545008097/FG241206A-03(06/08/2025), FG240917A-01(03/17/2025). APT-95/00857545008103/FG241206A-04(06/08/25)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1512-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1512-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-07

Product code NRY

K222786Class II072 Aspiration SystemQ'Apel Medical, Inc. / cleared 2023-08-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)