{"id":6125,"date":"2025-03-25T13:11:31","date_gmt":"2025-03-25T10:11:31","guid":{"rendered":"https:\/\/jordan-cardiac.org\/?p=6125"},"modified":"2025-03-25T13:11:31","modified_gmt":"2025-03-25T10:11:31","slug":"fda-class-i-recall-of-bard-peripheral-vasculars-rotarex-atherectomy-system","status":"publish","type":"post","link":"https:\/\/jordan-cardiac.org\/en\/fda-class-i-recall-of-bard-peripheral-vasculars-rotarex-atherectomy-system\/","title":{"rendered":"FDA Class I Recall of Bard Peripheral Vascular\u2019s Rotarex Atherectomy System"},"content":{"rendered":"<div>FDA Class I Recall of Bard Peripheral Vascular\u2019s Rotarex Atherectomy System<\/div>\n<div><\/div>\n<div>Highlighted by AHA , March 21, 2025<\/div>\n<div><\/div>\n<div>1. Recall Classification and Reason<\/div>\n<div><span> \u2022 The FDA has classified the recall as Class I, the most serious type, due to risks of serious injury or death.<\/span><\/div>\n<div><span> \u2022 The recall affects multiple models of Bard Peripheral Vascular\u2019s Rotarex Atherectomy System.<\/span><\/div>\n<div><span> \u2022 Issue: The helix portion of the device may fracture or break off during use, potentially leading to:<\/span><\/div>\n<div><span> \u2022 Vessel injury<\/span><\/div>\n<div><span> \u2022 Severe bleeding<\/span><\/div>\n<div><span> \u2022 Need for additional interventions<\/span><\/div>\n<div><span> \u2022 Death<\/span><\/div>\n<div><\/div>\n<div>2. Reported Adverse Events<\/div>\n<div><span> \u2022 115 cases required additional intervention.<\/span><\/div>\n<div><span> \u2022 30 serious injuries reported.<\/span><\/div>\n<div><span> \u2022 4 patient deaths linked to device failure.<\/span><\/div>\n<div><\/div>\n<div>3. FDA Actions &amp; Updated Usage Instructions<\/div>\n<div><span> \u2022 Devices are NOT being removed from the market but must be used following updated Instructions for Use (IFU).<\/span><\/div>\n<div><span> \u2022 Key safety measures include:<\/span><\/div>\n<div><span> \u2022 Use a kink-resistant sheath of the same or slightly larger size.<\/span><\/div>\n<div><span> \u2022 Avoid use in vessels with sharp curves (diameter &lt;4 cm).<\/span><\/div>\n<div><span> \u2022 Ensure continuous blood flow to prevent overheating or blockage.<\/span><\/div>\n<div><span> \u2022 Maintain constant movement to reduce stress on the helix.<\/span><\/div>\n<div><span> \u2022 Avoid calcified vessel segments longer than 10 mm.<\/span><\/div>\n<div><span> \u2022 Monitor for resistance, alarms, or motor pitch changes as signs to stop or flush the catheter.<\/span><\/div>\n<div><\/div>\n<div>For more details, refer to the FDA and Bard Peripheral Vascular\u2019s official advisory.<\/div>\n","protected":false},"excerpt":{"rendered":"<p>FDA Class I Recall of Bard Peripheral Vascular\u2019s Rotarex Atherectomy System Highlighted by AHA , March 21, 2025 1. Recall Classification and Reason \u2022 The FDA has classified the recall as Class I, the most serious type, due to risks of serious injury or death. \u2022 The recall affects multiple models of Bard Peripheral Vascular\u2019s [&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-6125","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6125","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=6125"}],"version-history":[{"count":1,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6125\/revisions"}],"predecessor-version":[{"id":6126,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/posts\/6125\/revisions\/6126"}],"wp:attachment":[{"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/media?parent=6125"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/categories?post=6125"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/jordan-cardiac.org\/en\/wp-json\/wp\/v2\/tags?post=6125"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}