Csi wirion recall
WebNov 25, 2024 · CSI recalls Wirion embolic protection device. 25th November 2024. 3322. Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic … The WIRION® system is used to hold and remove debris or blood clots from the lower limbs that can be associated with atherectomyExternal Link Disclaimerprocedures. See more Customers in the U.S. with questions about this recall should contact Cardiovascular Systems Inc. by phone at 651-259-2800. See more Cardiovascular Systems Inc. is recalling the WIRION system due to complaints of filter breakage during retrieval. Under certain … See more On November 22, 2024, Cardiovascular Systems Inc. sent an urgent notification recall letter to customers instructing them: 1. Remove the device from distribution and return the device to Cardiovascular Systems Inc. See more
Csi wirion recall
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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, … WebNov 24, 2024 · Cardiovascular Systems, Inc. (CSI®) (NASDAQ:CSII) has initiated a voluntary recall of unused WIRION Embolic Protection Systems (WIRION) due to complaints of filter breakage during retrieval.
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 … WebMar 14, 2024 · WIRION ® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified …
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 … 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 ...
WebNov 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 …
WebNov 22, 2024 · Action. Consignees were issued an URGENT: Medical Device Recall letter dated 11/22/2024. Consignees are asked to immediately remove from use and return affected devices to CSI. To do so: 1) Complete the attached Customer Acknowledgement Form. a) Per lot, document the quantity of all devices that are to be returned. how do trade winds affect climateWebNov 26, 2024 · CSI expects to introduce the acquired catheters as its new ViperCross line in the first half of its fiscal year, ending on 30 June 2024. Price Action: CSII shares closed … how much snow did madison wi get yesterdayWebAug 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. how do trade unions workWebFeb 8, 2024 · Cardiovascular Systems, Inc. Recall. On November 24, 2024, CSI announced the WIRION Embolic Protection System voluntary recall. The company initiated the … how do trade winds blowWebNov 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, … how do trade unions negotiate with employersWebNov 26, 2024 · Print. Cardiovascular Systems Inc. announced a voluntary recall of its Wirion device on Wednesday afternoon. The company has told health care facilities to … how do trademarks differ from copyrightsWebApr 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 … how much snow did mammoth get today