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
- Study: Long working hours alter brain regions tied to emotion, cognition
- Survey: Burnout, rigid schedules push nurses to leave
- UCLA surgeons perform world’s first bladder transplant
- AHA urges HHS to cut regulations that burden hospitals and staff
- Commentary: Overlooking, underfunding perioperative mental health threatens patients
- Study: Fewer men undergo unnecessary prostate cancer surgery amid rise in active surveillance
- OpenAI benchmarking tool tests healthcare LLMs
- Healthgrades recognizes top 15% of hospitals for patient experience in 2025
- Q1 reports show climb in outpatient surgical volume, diverging trends at Surgery Partners, Ardent Health
- Study: SGLT2 inhibitors raise postop euglycemic ketoacidosis risk but lower mortality
© Access Intelligence, LLC. All rights reserved. |
Privacy Policy |
Cookie Settings |
Diversity, Equity, Inclusion & Belonging |
Accessibility Statement