072 Aspiration System
Product details
- 072 Aspiration System
Company announcement
Q’Apel Medical Inc. initiated a worldwide recall of 1,617 units of its 072 Aspiration System (Hippo) due to concerns raised by the FDA regarding the distal tip design.
The product was distributed in the United States, Qatar, United Arab Emirates, and the Republic of Kazakhstan.
Adverse events reported include a tip detachment, a vessel rupture, and a vasospasm.
Risk:
The tip of any aspiration catheter used during a thrombectomy could potentially cause vasospasm and/or vascular injury. In particular, if the tip of an aspiration catheter triggers irritation of the vessel wall, it may manifest as vasospasm, which may be self-limiting or may require treatment (e.g., vasodilatation). Vascular injury may result in a non-flow limiting dissection that requires no intervention and causes no permanent morbidity, a flow-limiting dissection that requires intervention and may be associated with morbidity, or in the extreme case, vessel perforation or rupture which requires intervention and likely results in morbidity or even mortality. If unretrieved, a detached tip of a catheter could result in serious adverse events such as blockage of blood vessels, ischemia of end organs, and death.
Impacted states: US
Products:
- 072 Aspiration System (Hippo with Cheetah Delivery Tool) with Aspiration Tubing
- 072 Aspiration System (Hippo with Cheetah Delivery Tool)
- 072 Aspiration Tubing
Contact
For more information, call 510-738-6255 or email orders@qapelmedical.com.