{"id":6602,"date":"2025-04-23T12:50:28","date_gmt":"2025-04-23T09:50:28","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=6602"},"modified":"2025-04-23T12:50:28","modified_gmt":"2025-04-23T09:50:28","slug":"oct-and-ivus-imaging-catheters-of-coronary-arteries-withdrawn-for-safety-issues","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/oct-and-ivus-imaging-catheters-of-coronary-arteries-withdrawn-for-safety-issues\/","title":{"rendered":"OCT and IVUS imaging catheters of coronary arteries withdrawn for safety issues"},"content":{"rendered":"<div>OCT and IVUS imaging catheters of coronary arteries withdrawn for safety issues:<\/div>\n<div><span> 1. FDA Warning:<\/span><\/div>\n<div>The U.S. FDA issued a safety alert regarding catheters used with Conavi Medical\u2019s Novasight Hybrid System.<\/div>\n<div><span> 2. Recall Status:<\/span><\/div>\n<div>No official recall yet, but certain catheter lots are being voluntarily removed from the market.<\/div>\n<div><span> 3. Device Use:<\/span><\/div>\n<div>The Novasight Hybrid System is designed for OCT and IVUS imaging of coronary arteries.<\/div>\n<div><span> 4. Incident Triggering Alert:<\/span><\/div>\n<div>A catheter sheath detached during use and was left inside a patient\u2019s body, though it was successfully removed without further injury.<\/div>\n<div><span> 5. Potential Risks:<\/span><\/div>\n<div><span> \u2022 Coronary artery complications (e.g., spasm, dissection, perforation)<\/span><\/div>\n<div><span> \u2022 Thrombosis, embolism, or abrupt vessel closure<\/span><\/div>\n<div><span> \u2022 Hemodynamic issues: arrhythmias, hypotension, respiratory insufficiency<\/span><\/div>\n<div><span> \u2022 May require emergency cardiac surgery if retrieval fails<\/span><\/div>\n<div><span> 6. No Additional Cases Reported:<\/span><\/div>\n<div>As of now, this is an isolated incident.<\/div>\n<div><span> 7. Company Action:<\/span><\/div>\n<div>In March, Conavi Medical sent an Urgent Medical Device Product Removal notice to all affected healthcare providers, asking them to return unused products.<\/div>\n<div><span> 8. Next Steps for Providers:<\/span><\/div>\n<div>Healthcare providers are advised to monitor the FDA website for updates.<\/div>\n<div><span> 9. FDA Review Ongoing:<\/span><\/div>\n<div>The FDA is still evaluating the situation and will issue further guidance if a full recall is necessary.<\/div>\n<div><span> 10. Affected Lot Numbers:<\/span><\/div>\n<div><\/div>\n<div><span> \u2022 230902<\/span><\/div>\n<div><span> \u2022 240202<\/span><\/div>\n<div><span> \u2022 240302<\/span><\/div>\n<div><span> \u2022 240402<\/span><\/div>\n<div><span> \u2022 240502<\/span><\/div>\n","protected":false},"excerpt":{"rendered":"<p>OCT and IVUS imaging catheters of coronary arteries withdrawn for safety issues: 1. FDA Warning: The U.S. FDA issued a safety alert regarding catheters used with Conavi Medical\u2019s Novasight Hybrid System. 2. Recall Status: No official recall yet, but certain catheter lots are being voluntarily removed from the market. 3. Device Use: The Novasight Hybrid [&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-6602","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6602","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=6602"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6602\/revisions"}],"predecessor-version":[{"id":6603,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6602\/revisions\/6603"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6602"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6602"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6602"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}