Recall and Discontinuation of Q’Apel Medical’s 072 Aspiration System. Summary
Recall and Discontinuation of Q’Apel Medical’s 072 Aspiration System. Summary:
1. Device Affected: Q’Apel Medical’s 072 Aspiration System, which includes the Hippo aspiration catheter and Cheetah guiding system, used for stroke thrombectomy in cases of large vessel occlusion (LVO).
2. Reason for Recall: The U.S. FDA issued a warning letter citing concerns about the distal tip design of the Hippo catheter.
3. Recall Classification: The FDA classified the action as a Class I recall, indicating that use of the device may cause serious injury or death.
4. Company Action: Q’Apel Medical has voluntarily recalled and discontinued the device, stating it will focus on developing next-generation technologies.
5. Adverse Events: Three adverse events were reported:
• One tip detachment (resolved without harm)
• One vessel rupture
• One vasospasm
6. Geographic Distribution: The device was distributed in the U.S., Qatar, UAE, and Kazakhstan.
7. Recall Scope: A total of 1,617 device lots are included in the recall.
8. Next Steps for Users: Consignees are advised to return all unused inventory immediately and notify any third-party recipients.
9. Company Statement: Q’Apel believes other factors may have contributed to the events and is continuing to monitor the situation closely.
Source: U.S. Food and Drug Administration (FDA)
Full Advisory Link:https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fda-classifies-qapel-medical-incs-worldwide-medical-device-recall-and-discontinuation-its-072?utm_medium=email&utm_source=govdelivery#recall-announcement