{"id":6642,"date":"2025-05-05T12:27:43","date_gmt":"2025-05-05T09:27:43","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=6642"},"modified":"2025-05-05T12:27:58","modified_gmt":"2025-05-05T09:27:58","slug":"recall-and-discontinuation-of-qapel-medicals-072-aspiration-system-summary","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/recall-and-discontinuation-of-qapel-medicals-072-aspiration-system-summary\/","title":{"rendered":"Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System. Summary"},"content":{"rendered":"<p>Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System. Summary:<br \/>\n1. 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).<br \/>\n2. Reason for Recall: The U.S. FDA issued a warning letter citing concerns about the distal tip design of the Hippo catheter.<br \/>\n3. Recall Classification: The FDA classified the action as a Class I recall, indicating that use of the device may cause serious injury or death.<br \/>\n4. Company Action: Q\u2019Apel Medical has voluntarily recalled and discontinued the device, stating it will focus on developing next-generation technologies.<br \/>\n5. Adverse Events: Three adverse events were reported:<br \/>\n\u2022 One tip detachment (resolved without harm)<br \/>\n\u2022 One vessel rupture<br \/>\n\u2022 One vasospasm<br \/>\n6. Geographic Distribution: The device was distributed in the U.S., Qatar, UAE, and Kazakhstan.<br \/>\n7. Recall Scope: A total of 1,617 device lots are included in the recall.<br \/>\n8. Next Steps for Users: Consignees are advised to return all unused inventory immediately and notify any third-party recipients.<br \/>\n9. Company Statement: Q\u2019Apel believes other factors may have contributed to the events and is continuing to monitor the situation closely.<br \/>\nSource: U.S. Food and Drug Administration (FDA)<br \/>\nFull Advisory Link:<a href=\"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&amp;utm_source=govdelivery#recall-announcement\">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&amp;utm_source=govdelivery#recall-announcement<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Recall and Discontinuation of Q\u2019Apel Medical\u2019s 072 Aspiration System. Summary: 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-6642","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6642","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=6642"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6642\/revisions"}],"predecessor-version":[{"id":6643,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6642\/revisions\/6643"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6642"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6642"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6642"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}