Agency classClass IIOur severity:High FDA (Devices)·Z-0861-2014·Announced 2014-02-05

Codman Certas Programmable Valves Recalled for Potential Malfunction

Codman & Shurtleff is recalling 1,481 Codman Certas Programmable Valves because they may not operate properly, potentially affecting hydrocephalus management.

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 involves a risk-of-harm product (implantable medical device) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 1,481 units of the Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device (Product Code: 82-8804). The recall is due to a defect where 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 products 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 record Z-0861-2014.

Patients with these implanted devices should contact their healthcare provider for evaluation and potential replacement. The FDA classifies this as a Class II recall, indicating that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Codman Certas Programmable Valve In Line Valve only with SiphonGuard Device Product Code: 82-8804 Product Usage: The CODMAN CERTAS Programmable Valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the…
Manufacturer: Codman & Shurtleff, Inc.
Category: Medical Device — Neurological / Hydrocephalus
Hazard: malfunction
device-failure
Affected units: 1,481

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.

See all →

Moderate
Codman Galaxy G3 Mini Microcoil Delivery System Recalled for Labeling Error
FDA (Devices) · 2019-08-21
High
Codman 3000 Series Refill Set Recalled for Leaking Needles
FDA (Devices) · 2015-06-03
Severe
Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29
High
Codman EDS 3 Drainage System Recalled for Tubing Leak Risk
FDA (Devices) · 2014-10-29
Severe
Codman EDS 3 Drainage System Recalled for Potential CSF Leakage
FDA (Devices) · 2014-10-29

Same hazard · malfunction