Cardiovascular Systems Inc. announced a voluntary recall of its Wirion device on Wednesday afternoon. The company has told health care facilities to stop using the product and has alerted the U.S. Food and Drug Administration.
The Wirion Embolic Protection System is used during an above-the-knee atherectomy — a surgical procedure to remove plaque that narrows or blocks a patient's arteries. The device's filter catches debris, or arterial plaque, during the procedure that could create a new blockage and restrict blood flow.
New Brighton-based Cardiovascular Systems (CSI) said there have been nine complaints of the Wirion filter breaking while being removed after surgery. If the filter breaks, debris and parts of the filter would not be retrieved from a patient's body. That could cause restricted blood flow and could mean that patient would need additional procedures.
The company reported the first use of Wirion on U.S. patients in March. From March through Nov. 15, 697 of the devices were distributed.
The company plans to fix the issue and get the Wirion product back on the market.
"We intend to re-engineer the device and relaunch," said Jack Nielsen, a spokesman for CSI. A timetable is yet to be determined.
CSI did not develop the Wirion system. The company acquired it in 2019 deal from Gardia Medical, a wholly owned Israeli subsidiary of Allium Medical Solutions. Medtronic, Boston Scientific Corp. and Abbott Laboratories — major medtech players that all have a presence in Minnesota — produce similar devices.
The company expects to take a one-time charge of about $2.5 million related to the recall, CSI said in a filing with the U.S. Securities and Exchange Commission.
A few weeks ago, CSI reported disappointing results for its first fiscal quarter. Sales were down 3.6% for the quarter largely because of the ongoing impact of the pandemic and delays for elective surgery procedures.
"The pace of recovery is difficult to predict," said CSI CEO Scott Ward at the time.