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Csi wirion recall

WebNov 25, 2024 · Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic protection systems due to complaints of filter breakage during retrieval. Wirion … 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, …

Cardiovascular Systems Recalls Wirion Embolic Protection …

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 Web2 days ago · This product is distributed by CSI. Manufactured By. WIRION ® Peripheral Embolic Protection System. Indications Statement: WIRION® is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the … circuit city black friday deals https://lillicreazioni.com

CSI recalls WIRION Embolic Protection Systems - Medical Device …

WebFeb 8, 2024 · Cardiovascular Systems, Inc. Recall. On November 24, 2024, CSI announced the WIRION Embolic Protection System voluntary recall. The company initiated the recall of all unused devices “due to complaints of filter breakage during withdrawal.”. The company recalled all customer inventory of the WIRION Embolic Protection Device (Model WRN-D6). 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 … WebThe WIRION is indicated for use as an embolic protection system to contain and remove embolic material (thrombus/debris) while performing atherectomy in calcified lesions of the lower extremities. The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION may be used with commercially available 0. ... diamond creek apartments dallas tx

Indications Statements, Important Safety & Risk Information

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Csi wirion recall

Q4 FY19 Earnings Call

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, … WebMar 17, 2024 · Device offers a streamlined approach for lower extremity embolic protection Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII), a medical device company …

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 … WebSt. 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 …

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

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. WebNov 24, 2024 · November 24, 2024—Cardiovascular Systems, Inc. (CSI) announced it has initiated a voluntary recall of unused Wirion embolic protection systems because of …

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.

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 … diamond credit union near meWebMar 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 … diamond creek basketball clubWebMar 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 … diamond creek apts reno nvWebNov 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 … diamond creek bike trailWebAug 5, 2024 · CSI plans to commercialize the WIRION System in the United States following the transfer of manufacturing from Gardia Medical. CSI expects the manufacturing transfer to be completed after a 12- to ... diamond creek bowlsWebNov 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 … diamond credit union savings interest rateWebNov 24, 2024 · CSI has received nine complaints of filter breakage during retrieval. Filter breakage may result in device embolism and possible additional intervention; The company plans to voluntarily recall all Wirion units currently in customer inventory. In total, 697 devices were distributed in the U.S. this year between March 22 and Nov. 15 diamond creek banner elk