Integra Lifesciences Corp. (neurosciences): Shunt, Central Nervous System And Components
Recall Summary Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (product ID 37.550.501), which are medical devices used to drain fluid from the brain. The catheters were found to have higher-than-acceptable levels of endotoxins, a bacterial substance that can cause harmful reactions. The affected product was distributed nationwide to hospitals and medical facilities.
- Recalling firm
- Integra LifeSciences Corp. (NeuroSciences)
- 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.
- Reason
- Out-of-specification endotoxin result that did not meet the acceptance criteria.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-04-10
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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).
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/40ec7c06-2c50-4fb2-a2fb-9011584cf406