FDA-Device2026-05-20Class IIPROCESSING DEFECT
Integra Codman CerebroFlo EVD Catheter recalled for elevated endotoxin levels
What this means
Integra LifeSciences recalled Codman CerebroFlo EVD Catheters (Product ID 37.550.501, Lot 45322) because testing found endotoxin levels that exceeded safety standards. Endotoxins are bacterial fragments that can trigger harmful immune responses in patients. The affected catheters are used to drain fluid from the brain in hospital settings.
- If your facility received this product, do not use it and quarantine the affected lot immediately.
- Contact your hospital's medical device or infection control team and your supplier for return instructions.
- Check your inventory for Lot 45322 and verify product ID 37.550.501.
The agency's original wording
Hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Arizona (AZ), Arkansas (AR), California (CA), Connecticut (CT), Florida (FL), Kentucky (KY), Louisiana (LA), Michigan (MI), Minnesota (MN), Missouri (MO), North Carolina (NC), North Dakota (ND), Oklahoma (OK), Oregon (OR), Texas (TX), Washington (WA).
Affected count
40 packs (200 units)
Manufactured in
1100 Campus Rd, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2173-2026Want us to check the next one for you?
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