Integra LifeSciences recalls Codman CerebroFlo EVD catheters with endotoxin results outside safety limits. Affected units have Product ID 37.550.501. Contact for remedy details.
Out-of-specification endotoxin result that did not meet the acceptance criteria.
Integra LifeSciences is recalling Codman CerebroFlo EVD catheters with Endexo Technology due to endotoxin levels that don't meet safety standards. This could pose a risk to patients using the device for brain fluid drainage.
The catheter contains endotoxins that exceed safety limits. Endotoxins are bacterial components that can cause infections or other health issues when introduced into the body.
Patients using the Codman CerebroFlo EVD catheter for brain fluid drainage are most at risk. The recall affects specific units with Product ID 37.550.501.
Check for Product ID 37.550.501 on the catheter packaging. The catheter is a 3.3 mm diameter, 35 cm long polyurethane tube used for draining brain fluid.
Look for Product ID 37.550.501 on the catheter packaging or label.
The recall is due to endotoxin results that did not meet the safety acceptance criteria.
Product ID 37.550.501.
The recall record does not specify a remedy.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2173-2026 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-2173-2026 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
