Csi wirion recall
WebMar 17, 2024 · The diameter of the vessel at the site of filter basket placement should be between 3.5 to 6 mm. Wirion may be used with commercially available 0.014-inch guidewires, advised the company. In August 2024, CSI acquired the Wirion device and related assets from Gardia Medical Ltd., a wholly owned Israeli subsidiary of Allium … WebCSI representative or call customer service at 1-877-274-0901. PACKAGE INCLUDES: (1) Delivery Catheter with Pre-Loaded Filter, (1) Retrieval Catheter (1) Syringe with Flushing Tip (5 cc) WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy
Csi wirion recall
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WebAug 6, 2024 · Cardiovascular Systems (CSI) has purchased the Wirion embolic protection system and related assets from Gardia Medical for an undisclosed sum. Wirion secured CE mark approval in June 2015, while clearance from the US Food and Drug Administration (FDA) in March 2024. CSI chairman, president and CEO Scott Ward said: “The … WebAug 5, 2024 · The Wirion device is a distal embolic protection filter that is used to capture debris that can be associated with all types of peripheral vascular interventions. CSI plans to commercialize the Wirion system in the United States after the transfer of manufacturing from Gardia Medical, which is expected to be completed after a 12- to 15-month ...
WebJul 6, 2024 · CSI, based in St. Paul, Minnesota, sent an urgent recall notice to all affected customers asking them to discontinue use of all Wirion units and return unused product … WebNov 25, 2024 · Medical device company Cardiovascular Systems (CSI) has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION). The unused WRN …
WebNov 22, 2024 · Recall Status 1: Completed: Recall Number: Z-0394-2024: Recall Event ID: 89120: 510(K)Number: K210282 K213372 Product Classification: Temporary Carotid … WebMar 17, 2024 · Device offers a streamlined approach for lower extremity embolic protection Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII), a medical device company …
WebMar 17, 2024 · For example, statements in this press release regarding the benefits of the WIRION system; the commercialization of the WIRION system; and CSI’s …
WebNov 24, 2024 · The company plans to voluntarily recall all WIRION units currently in customer inventory. In total, 697 devices were distributed in the U.S. between March 22, 2024 and November 15, 2024. ooma wifi callingWebSt. Paul, Minn. – November 24, 2024 – Cardiovascular Systems, Inc. (CSI ... The company plans to voluntarily recall all WIRION units currently in customer inventory. In total, 697 … iowa city medical supply storeWebNov 26, 2024 · CSI has also notified the US Food and Drug Administration (FDA) regarding the voluntary recall. WIRION is a rapid exchange, pre-loaded filter, used as an embolic … ooma will not connectooma wifi phoneWebNov 24, 2024 · Cardiovascular Systems, Inc. has initiated a voluntary recall of unused WIRION Embolic Protection Systems due to complaints of filter breakage during retrieval. CSI has informed all affected... September 19, 2024 iowa city medical schoolWebNov 25, 2024 · CSI recalls Wirion embolic protection device. 25th November 2024. 3322. Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic protection systems due to complaints of filter breakage during retrieval. Wirion is a distal embolic protection filter used to capture thrombus and debris that can be associated with all types ... ooma windows app downloadWebApr 10, 2024 · Protecting reimbursement and coverage. At CSI, our commitment to patients, physicians and hospitals doesn’t end with delivering unique technology. Our team collaborates with leading experts and encourages policy organizations to support patient access and appropriate reimbursement for high-quality interventional treatments for PAD … ooma wifi dongle