Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2191-2014·Announced 2014-08-20

Codman Certas Valve Recalled for Pressure Specification Clarification

Codman & Shurtleff is recalling 9,498 Codman Certas valves to clarify the pressure specification for the virtual off setting in the product's Instructions for Use.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text indicates the action is to clarify a specification in the Instructions for Use rather than address a reported defect or injury, fitting the criteria for a moderate severity labeling/documentation issue.

Plain-English summary

Codman & Shurtleff, Inc. is recalling 9,498 units of the Codman Certas In Line Valve with SIPHONGUARD Device, Unitized BACTISEAL Catheter and Accessories (Product Code: 82-8807). The recall is initiated to clarify the pressure specification for the 'virtual off' setting (setting 8) as outlined in the product's Instructions for Use (IFU).

The affected devices are implantable valves used to provide constant intraventricular pressure and drainage of cerebrospinal fluid for the management of hydrocephalus. The recall covers devices distributed worldwide, including the United States and numerous international markets such as Canada, Australia, and various European and Middle Eastern countries.

Healthcare providers and patients should refer to the updated Instructions for Use for the correct pressure specifications regarding the virtual off setting. No specific instructions for consumer action are provided in the source text beyond the clarification of the IFU.

The recalled product

Product: Codman Certas - In Line Valve with SIPHONGUARD¿ Device, Unitized BACTISEAL¿ Catheter and Accessories; Product Code: 82-8807 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid)…
Manufacturer: Codman & Shurtleff, Inc.
Category: Medical Device — Implantable Valve
Hazard: mis-labeling
Affected units: 9,498

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

Lot Numbers: CLPCNB
CMBCPT
CMCC2W
CMDB6L
CMDDJV
CMI<B24
CMLCKN
CMMC3H
CMMCGV
CMNBZH
CNBB11
CNCB6N
CNCCLH
CNCCU
CNCCZ2
CNCCZ3
CNDB69
CNDB8C
CNDBRJ
CNDCVO

Distribution

Distributed in 43 states:

Part of a larger recall action

This product is one of 8 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 8 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 · mis labeling