{"id":6636,"date":"2025-05-05T11:53:23","date_gmt":"2025-05-05T08:53:23","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=6636"},"modified":"2025-05-05T11:57:55","modified_gmt":"2025-05-05T08:57:55","slug":"summary-recall-and-discontinuation-of-qapel-medicals-072-aspiration-system","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/summary-recall-and-discontinuation-of-qapel-medicals-072-aspiration-system\/","title":{"rendered":"Summary: Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System"},"content":{"rendered":"<div>Summary: Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System<\/div>\n<div><span> 1. Device Affected: Q\u2019Apel Medical\u2019s 072 Aspiration System, which includes the Hippo aspiration catheter and Cheetah guiding system, used for stroke thrombectomy in cases of large vessel occlusion (LVO).<\/span><\/div>\n<div><span> 2. Reason for Recall: The U.S. FDA issued a warning letter citing concerns about the distal tip design of the Hippo catheter.<\/span><\/div>\n<div><span> 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.<\/span><\/div>\n<div><span> 4. Company Action: Q\u2019Apel Medical has voluntarily recalled and discontinued the device, stating it will focus on developing next-generation technologies.<\/span><\/div>\n<div><span> 5. Adverse Events: Three adverse events were reported:<\/span><\/div>\n<div><span> \u2022 One tip detachment (resolved without harm)<\/span><\/div>\n<div><span> \u2022 One vessel rupture<\/span><\/div>\n<div><span> \u2022 One vasospasm<\/span><\/div>\n<div><span> 6. Geographic Distribution: The device was distributed in the U.S., Qatar, UAE, and Kazakhstan.<\/span><\/div>\n<div><span> 7. Recall Scope: A total of 1,617 device lots are included in the recall.<\/span><\/div>\n<div><span> 8. Next Steps for Users: Consignees are advised to return all unused inventory immediately and notify any third-party recipients.<\/span><\/div>\n<div><span> 9. Company Statement: Q\u2019Apel believes other factors may have contributed to the events and is continuing to monitor the situation closely.<\/span><\/div>\n<div><\/div>\n<div>\u2e3b<\/div>\n<div><\/div>\n<div>Source: U.S. Food and Drug Administration (FDA)<\/div>\n<div>Full Advisory Link: FDA Recall Notice \u2013 Q\u2019Apel 072 Aspiration System<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Summary: Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System 1. Device Affected: Q\u2019Apel Medical\u2019s 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 [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-6636","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6636","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/comments?post=6636"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6636\/revisions"}],"predecessor-version":[{"id":6637,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6636\/revisions\/6637"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6636"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6636"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6636"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}