January 11, 2022
FDA: Class I recall of Cardiovascular Systems’ WIRION Embolic Protection Device
Editor's Note
The Food and Drug Administration (FDA), on January 10, identified the recall of Cardiovascular Systems’ WIRION Embolic Protection Device as Class I, the most serious.
The device, which is used to hold or remove debris or blood clots from the lower limbs, was recalled because of complaints of filter breakage during retrieval.
Cardiovascular Systems has received reports of nine device malfunctions and no reports of deaths.
Distribution dates were March 22, 2021, to November 15, 2021.
Free Daily News
- Robotic surgery transforms ORs as market expands
- Study: Wildfire smoke raises hospital borrowing, patient care costs
- Study: Hospital bed shortage looms as aging population drives demand
- FDA designates Class 1 recall for pacemakers
- Chinese medical devices threaten US healthcare cybersecurity
- Preoperative SGLT2i use does not raise DKA risk in emergency surgery
- AI boosts accuracy in surgical reports, outperforming surgeons
- AI models improve prediction of surgical complications using preoperative clinical notes
- Ambient AI healthcare documentation gains traction as capabilities expand
- Healthcare M&A faces tighter review as FTC retains guidelines
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement