FDA recall, , Moderate risk
Codman CerebroFlo EVD Catheter with Endexo Technology
The CerebroFlo EVD Catheter has an out-of-specification endotoxin result that did not meet acceptance criteria.
Summary by Recall Canary from the FDA notice
What happened
Integra LifeSciences Corp. (NeuroSciences), based in Princeton, New Jersey, recalled the Codman CerebroFlo EVD Catheter with Endexo Technology because of an out-of-specification endotoxin result that did not meet the acceptance criteria. The product contains 5 sets with 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. The company began the recall on April 10, 2026, and it was added to the FDA's Enforcement Report on May 13, 2026.
Distribution was nationwide in the states of Arizona, Arkansas, California, Connecticut, Florida, Kentucky, Louisiana, Michigan, Minnesota, Missouri, North Carolina, North Dakota, Oklahoma, Oregon, Texas, and Washington.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is your set affected?
Match the UDI-DI and lot code listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter
- UDI-DI
- 10381780530138
- Lot code
- 45322
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Arizona (Arizona), Arkansas (Arkansas), California (California), Connecticut (Connecticut), Florida (Florida), Kentucky (Kentucky), Louisiana (Louisiana), Michigan (Michigan), Minnesota (Minnesota), Missouri (Missouri), North Carolina (North Carolina), North Dakota (North Dakota), Oklahoma (Oklahoma), Oregon (Oregon), Texas (Texas), Washington (Washington).
- Company
- Integra LifeSciences Corp. (NeuroSciences)Princeton, New Jersey
- Hazard
- Quality testing problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98752
- Recall number
- Z-2173-2026
- Quantity recalled
- 40 packs (200 units)
All recalls from Integra LifeSciences Corp. (NeuroSciences)
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
