Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID:... recall (Integra LifeSciences Corp. (NeuroSciences))
Medical deviceClass IIOngoing
Summary: Integra LifeSciences Corp. (NeuroSciences) is recalling 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 n. Reason: Out-of-specification endotoxin result that did not meet the acceptance criteria.
What is being 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.
Why
Out-of-specification endotoxin result that did not meet the acceptance criteria.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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). (states named: Arkansas, Arizona, California, Connecticut, Florida, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Oregon, Texas, Washington)
How to tell if yours is affected
Product ID: 37.550.501. UDI-DI: 10381780530138. Lot Number: 45322.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2173-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 10, 2026 |
| Reported | May 20, 2026 |
| Company | Integra LifeSciences Corp. (NeuroSciences) |
| Company location | Princeton, NJ, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 40 packs (200 units) |
More recalls from Integra LifeSciences Corp. (NeuroSciences) · all medical device recalls · recalls from April 2026