072 Aspiration System recallZ-1512-2025 · Qapel Medical Inc. · initiated Feb 26, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Qapel Medical Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Aspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm could occur.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-1512-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 26, 2025
- Posted by the FDA
- Apr 7, 2025
- Recalling firm
- Qapel Medical Inc.
- Quantity
- 1617
- Product code
- NRY
- FDA submissions
- K222786
- 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 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
Code information (models, lots, serial numbers)
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)
Devices named in this recall
3 devices in the FDA device registry whose identifier appears in the recall's code information.
- 072 Aspiration System FG 00806Q'Apel Medical LLC · Catheter, Thrombus Retriever1 recall3 reports
- 072 Aspiration System FG 00995Q'Apel Medical LLC · Catheter, Thrombus Retriever1 recall0 reports
- 072 Aspiration System FG 01252Q'Apel Medical LLC · Catheter, Thrombus Retriever1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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