2024 Csi wirion recall

Csi wirion recall

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August undefined, 2024

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 … 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 recalls Wirion embolic protection device - Cardiovascular …

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 … 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 … flowing keyboard

Cardiovascular Systems recalls Wirion medical device

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. 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 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 ... greencastle commercial roof repair

CSI recalls Wirion embolic protection device - Interventional News

Class 1 Device Recall WIRION EMBOLIC PROTECTION SYSTEM

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 · 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 flowing knee length dressesWebApr 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 … flowing lace

"WebNov 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 ... " - Csi wirion recall

Csi wirion recall

Cardiovascular Systems Recalls Embolic Protective Device

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 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.

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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 is a distal embolic protection filter used … WebNov 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 …

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 …

WebApr 6, 2024 · Cardiovascular Systems, Inc. (CSI ® ) (NASDAQ: CSII) has initiated a voluntary recall of unused WIRION Embolic Protection Systems (WIRION) due to … 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 …

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 … flowing lace wedding dressesWebNov 25, 2024 · CSI recalls Wirion embolic protection device. 25th November 2024. 3322. Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic … greencastle commercial rooferWebMar 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 … greencastle community schools employmentWebNov 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, … flowing lake boat launchWebFeb 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% ... greencastle community school corporation jobsWebAug 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 ... greencastle community centerWebAug 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 ... greencastle community schools enrollment