Cardiovascular Systems Inc (NASDAQ: CSII) is recalling all of its Wirion embolic protection system devices manufactured and distributed between January and November 2021.
- The Wirion system includes a filter inserted through a blood vessel in the leg via a catheter.
- The filter catches and removes any blood clots or debris floating in the bloodstream during an atherectomy procedure to remove plaque build-ups linked to peripheral artery disease.
- In some cases, however, including when the filter basket becomes too full, the Wirion device may be challenging to withdraw using the retrieval catheter, potentially causing the filter to tear or separate from the catheter.
- If that happens, it could require further medical procedures, allow a blood clot or other material to block the bloodstream, or lead to other serious complications, including death.
- Because of that potential risk, the FDA has given Cardiovascular Systems’ recall a Class I rating.
- In late November, the Company initiated its voluntary recall of all unused Wirion devices. Cardiovascular Systems had received nine complaints about the filter breaking during removal, with no deaths linked to the issue.
- 697 devices were distributed in the U.S. between March and November of 2021.
- Price Action: CSII shares closed at $19.14 on Tuesday.
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