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FDA announces recall of nearly 700 Embolic Protection Devices

The FDA announced Nov. 22, 2020 that Cardiovascular Systems has recalled its Wirion embolic protection device. The device’s filter can break off upon removal. The recall covers 697 devices.

Wirion designed the device to hold and remove blood clots or other debris from a patient’s lower limbs. It was typically used during an atherectomy procedure.

What Is an Atherectomy? 

Stanford Healthcare explains that an atherectomy is a procedure used to remove plaque from an artery or blood vessel. Removing plaque widens the artery, which allows blood to flow more freely to the heart muscles. A surgeon shaves or vaporizes plaque in the procedure, using tiny rotating blades or a laser on the end of a thin, flexible tube called a catheter.

An Atherectomy  is used to treat peripheral artery disease and coronary artery disease. The procedure is sometimes performed on patients with very hard plaque, or on those who have already had angioplasty and stents implanted, but who still have plaque blocking blood flow.

Wirion Recall

Wirion stated in the recall: “Under certain circumstances, such as when the filter basket is too full, the filter assembly may become difficult to withdraw. In this situation, withdrawal may cause the WIRION system filter component to tear or separate, which may result in series (sic) adverse events such as embolization, need for additional medical procedures, or possibly death.”

Class I Recall: Serious Injuries or Death

This is a Class I recall, meaning the use of this device “may cause serious injuries or death.” Nine malfunctions have been reported to date (Jan. 12, 2021), but no deaths. Devices included in the recall were made from January 2021 to August 2021. They were implanted in customers from March 2021 to November 2021.

Customers still in possession of one of these devices are advised to return it to Cardiovascular Systems.

Here’s the full advisory on the FDA’s website.

Cardiovascular Systems, Inc. recalls WIRION Embolic Protection Device over Complaints of Retrieval Problems

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Product (Include the following information)

  • Product Names: WIRION Embolic Protection Device
  • Product Codes: See Recall Database Entry
  • Model Numbers: All products and lots
  • Manufacturing Dates: January 3, 2021 to August 16, 2021
  • Distribution Dates: March 22, 2021 to November 15, 2021
  • Devices Recalled in the U.S.: 697
  • Date Initiated by Firm: November 22, 2021

What to Do

On November 22, 2021, Cardiovascular Systems Inc. sent an urgent notification recall letter to customers instructing them:

  • Remove the device from distribution and return the device to Cardiovascular Systems Inc.

Contact Information

Customers in the U.S. with questions about this recall are urged to contact Cardiovascular Systems Inc. by phone at 651-259-2800.

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