Cardiovascular Systems, Inc. Initiates Voluntary Recall of WIRION® Embolic Protection System
November 24 2021 - 4:05PM
Business Wire
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.
CSI has informed all affected healthcare facilities to
discontinue use of WIRION immediately and return unused product to
CSI. The U.S. Food and Drug Administration (FDA) has also been
notified. To date, CSI has received 9 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. between March 22, 2021 and November 15,
2021. All lots of the following models are being recalled:
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 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 Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
innovative solutions for treating vascular and coronary disease.
The company’s orbital atherectomy system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
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version on businesswire.com: https://www.businesswire.com/news/home/20211124006245/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com 1225 Old Highway 8 NW St. Paul, MN 55112
www.csi360.com
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