FDAHealthApril 10, 2026

Integra LifeSciences Corp. (NeuroSciences) — 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.

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

Is this relevant to me?

Geography: Nationwide
Source agency: FDA
Category: Health
Published: April 10, 2026

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).

What's affected?

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.
Brand: Integra LifeSciences Corp. (NeuroSciences)
Lot code: 45322

Additional details

Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 40 packs (200 units).

View original FDA notice →

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