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2021-11-26

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Cardiovascular Systems Recalls Wirion Embolic Protection System

Cardiovascular Systems Inc has commenced a voluntary recall of its WIRION Embolic Protection Systems

Cardiovascular Systems Recalls Wirion Embolic Protection System

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overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nCardiovascular Systems Recalls Wirion Embolic Protection System\n</h2>\n\n<h4 class=\"meta\">\n\n\n2021-11-26 21:44 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://www.benzinga.com/news/21/11/24302601/cardiovascular-systems-recalls-wirion-embolic-protection-system><strong>Benzinga</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Cardiovascular Systems Inc has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION).\n\nThe unused WRN-D6 models of the WIRION device are being recalled due to receiving ...</p>\n\n<a href=\"https://www.benzinga.com/news/21/11/24302601/cardiovascular-systems-recalls-wirion-embolic-protection-system\">Web Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","type":0,"thumbnail":"","relate_stocks":{"CSII":"Cardiovascular Systems"},"source_url":"https://www.benzinga.com/news/21/11/24302601/cardiovascular-systems-recalls-wirion-embolic-protection-system","is_english":true,"share_image_url":"https://static.laohu8.com/e9f99090a1c2ed51c021029395664489","article_id":"1182136836","content_text":"Cardiovascular Systems Inc has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION).\n\nThe unused WRN-D6 models of the WIRION device are being recalled due to receiving complaints regarding filter breakage at the time of retrieval.\nThe Company stated that the filter breakage might cause device embolism as well as additional intervention.\nAll affected healthcare facilities were informed to stop using and return the unused WIRION devices to the Company.\nCSI has also notified the FDA regarding the voluntary recall.\nThe Company has received nine filter breakage complaints so far and plans to recall all the devices currently in customer inventory.\nBetween 22 March and 15 November, approximately 697 devices were distributed in the US.\nWIRION is a rapid exchange, pre-loaded filter used as an embolic protection system for removing embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities.\nIn March, CSI acquired a portfolio of peripheral support catheters from WavePoint Medical.\nThese catheters are used during peripheral vascular intervention (PVI) procedures for guidewire support to aid in lesion crossing and for guidewire exchanges.\nCSI expects to introduce the acquired catheters as its new ViperCross line in the first half of its fiscal year, ending on 30 June 2022.\nPrice Action: CSII shares closed at $23.72 on Wednesday.","news_type":1,"symbols_score_info":{"CSII":0.9}},"isVote":1,"tweetType":1,"viewCount":2710,"commentLimit":10,"likeStatus":false,"favoriteStatus":false,"reportStatus":false,"symbols":[],"verified":2,"subType":0,"readableState":1,"langContent":"CN","currentLanguage":"CN","warmUpFlag":false,"orderFlag":false,"shareable":true,"causeOfNotShareable":"","featuresForAnalytics":[],"commentAndTweetFlag":false,"andRepostAutoSelectedFlag":false,"upFlag":false,"length":7,"xxTargetLangEnum":"ZH_CN"},"commentList":[],"hasMoreComment":false,"orderType":2}

Cardiovascular Systems Recalls Wirion Embolic Protection System

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