Medical device recalls Moderate risk

Integra LifeSciences Corp. (NeuroSciences) recalls Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Cath…

Recall date
April 10, 2026
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-2173-2026
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp. (NeuroSciences)
Sold / distributed
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).

Why it was recalled

Out-of-specification endotoxin result that did not meet the acceptance criteria.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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