CLASS I ONGOING Device recall · Reported 16 Apr 2025 · FDA Enforcement Report
Hippo 072 Aspiration System including Cheetah Delivery Tool recalled
Qapel Medical is recalling Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing, distributed in 29 states. The recall was initiated on 26 Feb 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1512-2025
- FDA event ID
- 96492
- Recalling firm
- Qapel Medical, Fremont, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 26 Feb 2025
- FDA classified
- 7 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 26 Feb 2025 | Recall initiated by company | |
| 7 Apr 2025 | Classified by FDA | +40 days |
| 16 Apr 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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
AlabamaArizonaCaliforniaConnecticutFloridaGeorgiaIdahoIllinoisIndianaLouisianaMassachusettsMichiganMinnesotaMissouriNorth CarolinaNorth DakotaNebraskaNew JerseyNevadaNew York
Questions about this recall
Why was it 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.
Which lots are affected?
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)
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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