Agency classClass IIOur severity:High FDA (Devices)·Z-0863-2014·Announced 2014-02-05

Codman Certas Programmable Valves Recalled for Potential Malfunction

Codman & Shurtleff, Inc. is recalling 409 units of Codman Certas Programmable Valves because they may not operate properly.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 recall is classified as FDA Class II, and the hazard involves a critical implantable device that may not operate properly, posing a risk of harm without reported injuries or fatalities.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 409 units of the Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories (Product Code: 82-8806). The recall is due to a defect where the valves may not operate properly.

The Codman Certas Programmable Valve is an implantable medical device used to provide constant intraventricular pressure and drainage of cerebrospinal fluid (CSF) for the management of hydrocephalus. The device allows for non-invasive reading or adjustment of the valve setting via the Codman Certas Therapy Management System.

The affected units were distributed worldwide, including the United States, Australia, Austria, Belgium, Brazil, Switzerland, Czech Republic, Germany, Spain, Finland, France, Great Britain, Israel, Italy, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, Slovenia, Slovakia, Turkey, South Africa, and the UK. Patients with these implanted devices should contact their healthcare provider for evaluation and appropriate management.

The recalled product

Product: Codman Certas Programmable Valve In Line Valve with Siphonguard, Unitized Catheter and Accessories Product Code: 82-8806 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF…
Manufacturer: Codman & Shurtleff, Inc.
Category: Medical Device — Neurological / Hydrocephalus
Hazard: device-malfunction
Affected units: 409

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 →

Same manufacturer · Codman & Shurtleff, Inc.

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Same hazard · device malfunction