FDAFDA · Food and drugs·Recall number Z-2173-2026
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.
Published May 20, 2026 · Recall initiated: April 10, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Out-of-specification endotoxin result that did not meet the acceptance criteria.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Integra LifeSciences Corp. (NeuroSciences)
- Distributor
- 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).
- Lot
- Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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