Sam Brusco, Associate Editor11.29.21
Cardiovascular Systems Inc. (CSI) began a voluntary recall of unused WIRION Embolic Protection Systems because of complaints about filters breaking during retrieval. Filter breakage can result in device embolism and a possible additional intervention.
CSI notified all affected healthcare facilities to stop using WIRION immediately and return unused products to the company. The FDA has also been informed. CSI has received nine complaints concerning filter breakage during retrieval to date.
The firm will voluntarily recall all WIRION units in customer inventory. 697 devices were distributed in the U.S. between March 22 and November 15 of this year. All lots of the model WRN-D6 WIRION Embolic Protection Device are being recalled.
Physicians and clinics are urged to direct questions to their CSI representative or call ^651) 259-2800). Adverse reactions or quality problems should be reported to the FDA MedWatch Adverse Event Reporting program online, by mail, or by fax.
CSI notified all affected healthcare facilities to stop using WIRION immediately and return unused products to the company. The FDA has also been informed. CSI has received nine complaints concerning filter breakage during retrieval to date.
The firm will voluntarily recall all WIRION units in customer inventory. 697 devices were distributed in the U.S. between March 22 and November 15 of this year. All lots of the model WRN-D6 WIRION Embolic Protection Device are being recalled.
Physicians and clinics are urged to direct questions to their CSI representative or call ^651) 259-2800). Adverse reactions or quality problems should be reported to the FDA MedWatch Adverse Event Reporting program online, by mail, or by fax.