# Major Recall Alert: 072 Aspiration System Recalled Due to Distal Tip Design Outside Scope of 510(k) Clearance
Q’Apel Medical, a prominent name in neurovascular device innovation, has issued an urgent recall of its 072 Aspiration System (also known as Hippo and Cheetah) following findings by the U.S. Food and Drug Administration (FDA) that the distal tip design is outside the scope of its 510(k) clearance. The FDA classified this as a **Class I recall**, denoting serious risks that could result in harm to patients.
Read on for critical information about this recall, the affected products, and important steps to take.
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## Why This Recall is Important
The safety of medical devices is paramount, especially those used for life-saving procedures like thrombectomies. The distal tip design flaw in the 072 Aspiration System could potentially result in severe complications, including:
- **Tip detachment** – leading to blockage of blood vessels, ischemia, or in worst cases, death.
- **Vascular injury** – ranging from slight vessel irritation to rupture or perforation.
- **Vasospasm** – causing restricted blood flow that may require medical intervention.
While only three adverse medical events have been reported, including a tip detachment (retrieved without injury), a vessel rupture, and a vasospasm, these risks highlight why the FDA classified this recall as a Class I – its most serious type of recall.
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## Details of the Recall
On **April 7, 2025**, the FDA officially categorized Q’Apel Medical’s voluntary recall, initiated on **February 26, 2025**, as a Class I recall. The decision follows a Warning Letter sent by the FDA, which questioned whether the product’s distal tip design met the 510(k) clearance specifications.
### Key Facts:
- **Affected Product**: 072 Aspiration System (branded as Hippo and Cheetah).
- **Number of Units Recalled**: 1,617.
- **Distributed Regions**: United States, Qatar, United Arab Emirates, and Kazakhstan.
- **Company Action**: Discontinued the 072 Aspiration System line, refocusing on newer technologies.
Although adverse reactions are a known risk associated with most aspiration catheters, Q’Apel has chosen to prioritize patient safety and proactively remove affected products from the market.
For more details, visit the **official FDA recall page**: [FDA Recall Alert](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072).
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## What You Should Do
If you or your organization uses the 072 Aspiration System, take the following actions immediately:
- **Check Inventory**: Identify and set aside any affected products.
- **Stop Use**: Discontinue use of the recalled product immediately.
- **Return Products**: Contact Q’Apel Medical Customer Service for instructions:
- Phone: **510-738-6255**
- Email: **orders@qapelmedical.com**
- Service Hours: Monday – Friday, 8:00 a.m. to 5:00 p.m. PT
- **Notify Others**: If you have distributed the product to others, inform Q’Apel immediately so further recall actions can be taken.
Healthcare providers and users are also encouraged to report any adverse reactions or quality issues to the FDA’s **MedWatch Adverse Event Reporting program**.
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To learn more about Q’Apel Medical’s commitment to innovation and the evolving neurovascular field, visit their official website at [qapelmedical.com](https://www.qapelmedical.com).