Official recall notice
FDA DeviceClass IINotable
Codman CerebroFlo EVD Catheter Recall (May 2026)
Product: Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series of drainage holes near the catheter's bullet shaped tip.
- Recall date
- 2026-05-20
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Product description
Out-of-specification endotoxin result that did not meet the acceptance criteria.