Cardiovascular Systems, Inc. Initiates Voluntary Recall of WIRION® Embolic Protection System
Cardiovascular Systems, Inc. (CSII) has issued a voluntary recall of the WIRION Embolic Protection Systems due to complaints of filter breakage during retrieval.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
CSI has informed all affected healthcare facilities to discontinue use of WIRION immediately and return unused product to CSI. The
The company plans to voluntarily recall all WIRION units currently in customer inventory. In total, 697 devices were distributed in the
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 regular mail or by fax:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 (http://www.fda.gov/MedWatch/getforms.htm)
About
View source version on businesswire.com: https://www.businesswire.com/news/home/20211124006245/en/
Vice President, Investor Relations & Corporate Communications
(651) 202-4919
j.nielsen@csi360.com
www.csi360.com
Source: