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 Certas - In Line Valve with SIPHONGUARD¿ Device Recalled by Codman & Shurtleff, Inc. Due to To clarify the CODMAN CERTAS Valve virtual off...

Date: July 3, 2014
Company: Codman & Shurtleff, Inc.
Status: Terminated
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 Codman & Shurtleff, Inc. directly.

Affected Products

Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Catheter and Accessories; Product Code: 82-8805 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus.

Quantity: 9,498 devices total

Why Was This Recalled?

To clarify the CODMAN CERTAS Valve virtual off (setting 8) pressure specification outlined in the product's Instructions for Use (IFU).

Where Was This Sold?

This product was distributed to 43 states: AL, AZ, CA, CO, CT, DE, FL, GA, ID, IL, IN, IA, KY, LA, ME, MD, MA, MI, MN, MO, MT, NE, NV, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VT, VA, WA, WV, WI, WY, DC

Affected (43 states)Not affected

About Codman & Shurtleff, Inc.

Codman & Shurtleff, Inc. has 58 total recalls tracked by RecallDetector.

Related Recalls

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