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Csi wirion recall

WebNov 22, 2024 · Recall Status 1: Completed: Recall Number: Z-0394-2024: Recall Event ID: 89120: 510(K)Number: K210282 K213372 Product Classification: Temporary Carotid … 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 …

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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 … 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 … chrome shelving 24x18x72 https://redrockspd.com

Cardiovascular Systems Recalls Wirion Embolic Protection …

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 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 … 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, … chrome shelves with bins

Cardiovascular Systems, Inc. Reports Fiscal 2024 Second ... - Benzinga

Category:Cardiovascular Systems, Inc Recalls WIRION Embolic …

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Csi wirion recall

Reimbursement Coding CSI360

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

Csi wirion recall

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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 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 ...

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 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

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.

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

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% ... chrome shelves 5 tierWebFeb 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). chrome shield regiosWebNov 25, 2024 · Cardiovascular Systems has initiated a voluntary recall of unused Wirion embolic protection systems due to complaints of filter breakage during retrieval. Wirion … chrome shelves sam\u0027s clubWebNov 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, … chrome shelves 5 tier 24WebAug 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 ... chrome shiftWebMar 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 … chrome shelving unit with castersWebNov 25, 2024 · Medical device company Cardiovascular Systems (CSI) has commenced a voluntary recall of its WIRION Embolic Protection Systems (WIRION). The unused WRN … chrome shichang