Codman EDS 3 Drainage System Recalled for Tubing Leak Risk
Codman & Shurtleff is recalling 93,558 EDS 3 Drainage Systems because tubing may leak or disconnect, risking improper fluid drainage or air introduction.
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 recall involves a high-risk medical device with a defect that can cause serious physiological harm (pneumocephalus or improper drainage), but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Codman & Shurtleff, Inc. is recalling 93,558 units of the Codman EDS 3 Drainage System (no Ventricular Catheter), Catalog Number 82-1731. The recall covers all lots with expiration dates on or before August 2017. The product is indicated for draining cerebrospinal fluid (CSF) to reduce intracranial pressure when a permanent internal shunt is not indicated.
The recall was initiated because the tubing within the system that drains CSF may leak or disconnect from the joints. This defect may result in over- or under-drainage of CSF from the ventricular system or the introduction of air into the ventricular system, a condition known as pneumocephalus.
The affected products were distributed worldwide, including nationwide in the United States and to numerous international locations. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Codman EDS 3 Drainage System (no Ventricular Catheter) (External Drainage System) Catalog Number: 82-1731 Indicated for draining cerebrospinal fluid (CFS) and other fluids of similar physical characteristics as a means of reducing intracranial pressure and CSF volume when the
- Manufacturer
- Codman & Shurtleff, Inc.
- Affected units
- 93,558
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 (1)
- All lots with expiration on or before August 2017 (2017-08)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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.
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