Csi wirion recall

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August undefined, 2024

WebAug 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 ... 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.

CSI recalls Wirion embolic protection device - Interventional News

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. 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 … pop up parade wendy australia

Class 1 Device Recall WIRION EMBOLIC PROTECTION …

WebFeb 8, 2024 · Cardiovascular Systems, Inc. Recall. On November 24, 2024, CSI announced the WIRION Embolic Protection System voluntary recall. The company initiated the … 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. All lots ... 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 … pop-up partytent

Cardiovascular Systems, Inc Recalls WIRION Embolic …

Cardiovascular Systems, Inc. Initiates Voluntary Recall of WIRION ...

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 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 … sharon mennonite bible institute singersWebAug 6, 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 15-month transition period. Gardia will retain the rights to the WIRION System for angioplasty and stenting procedures in the carotid arteries. sharon mennonite church

"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 … " - Csi wirion recall

Csi wirion recall

CSI recalls Wirion embolic protection device - Cardiovascular News

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% ... 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

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WebNov 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 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. ...

WebMar 17, 2024 · Device offers a streamlined approach for lower extremity embolic protection Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII), a medical device company … WebNov 25, 2024 · Medical device company Cardiovascular Systems (CSI) has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION). The unused WRN …

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 …

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 … sharon memory careWebNov 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 … pop up partytent 3x3WebApr 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 … sharon mental healthWebAug 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. sharon merchant west palm beachWebNov 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, … pop up parade towa higurashiWebNov 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 sharon messics mdWebNov 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, … sharon metal services limited