Csi wirion recall
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, … WebFeb 3, 2024 · Conference Call Scheduled for Today, February 3, 2024, at 8:00 a.m. CT (9:00 a.m. ET) Revenues of $59.1 million increased 1.3% sequentially compared to first quarter this year and decreased 7.8% ...
Csi wirion recall
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Web2 days ago · Individualized Solutions. CSI is a cardiovascular medical device company focused on the development and commercialization of innovative solutions for treating complex peripheral vascular disease and … WebNov 26, 2024 · Benzinga. Nov. 26, 2024, 07:55 AM. Cardiovascular Systems Inc (NASDAQ:CSII) has commenced a voluntary recall of its WIRION Embolic Protection …
WebAug 6, 2024 · presentation regarding CSI’sgrowth, future financial measurements, product development and introductions (including the timing thereof), clinical trials (including the timing thereof), international expansion, the timing of manufacturing transfer of the WIRION system, product benefits, and market opportunities, are forward-looking statements.
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 6, 2024 · Medical device company Cardiovascular Systems (CSI) has acquired the Wirion Embolic Protection System and related assets from Allium Medical Solutions’ wholly owned Israeli subsidiary Gardia Medical.. The Wirion System received the CE Mark in June 2015 and approval from the US FDA in March last year. The easy-to-use distal embolic …
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.
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 ... solar chargers for phoneWebNov 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, … slumberland furniture moorhead mnWebNov 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, … slumberland furniture osage beachWebNov 24, 2024 · Name: WIRION Embolic Protection Device Model: WRN-D6. Physicians and healthcare facilities can direct questions to their CSI representative or, call 651-259-2800. Adverse reactions or quality problems experienced with the use of the WIRION System may be reported to the FDA MedWatch Adverse Event Reporting program either online, by … slumberland furniture moorheadWebCSI 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 solar charging cableWebNov 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 solar charger with ac inputWebMar 17, 2024 · Device offers a streamlined approach for lower extremity embolic protection Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII), a medical device company … slumberland furniture mexico missouri