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w8w8
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w8w8
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2021-11-26
Sreamed
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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2021-09-21
$AGC Inc.(ASGLY)$
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2021-09-20
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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 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