Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining Recalled by Integra LifeSciences Corp. Due to Defect in the external sterile packaging (pouch) leading...

Date: May 7, 2024
Company: Integra LifeSciences Corp.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Integra LifeSciences Corp. directly.

Affected Products

CODMAN EVD BACTISEAL 1.9mm I.D. Catheter Set- indicated for gaining access to the ventricles of the brain and can be used with dimensionally compatible devices for draining cerebrospinal fluid (CSF) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume. Product Number: 821749

Quantity: 106 units

Why Was This Recalled?

Defect in the external sterile packaging (pouch) leading to a gap or/and weakness of the seal may compromise the product sterility.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Integra LifeSciences Corp.

Integra LifeSciences Corp. has 216 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report