The Recall Desk
HighFDA (Devices)·Z-0858-2014·Announced 2014-02-05

Codman Certas Programmable Valves Recalled for Potential Malfunction

Codman & Shurtleff is recalling 1,460 Certas Programmable Valves used for hydrocephalus because they may not operate properly.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall for a medical device that may not operate properly, which fits the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 1,460 units of the Codman Certas Programmable Valve (Product Code: 82-8800). The recall is due to a risk that the valves may not operate properly. These implantable devices are used to provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus.

The affected valves were distributed worldwide, including in the United States, Australia, Austria, Belgium, Brazil, Switzerland, and numerous other countries. The recall covers specific lot codes, which are listed in the official FDA recall notice Z-0858-2014.

Patients who have these valves implanted should contact their healthcare provider for guidance on monitoring and potential corrective actions. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Codman Certas Programmable Valve In Line Valve Only Product Code: 82-8800 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocepha
Manufacturer
Codman & Shurtleff, Inc.
Category
Medical Device — Neurological
Hazard
Affected units
1,460

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Codman & Shurtleff, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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