Codman Lumbar Drainage Catheter Kit Recalled for Potential CSF Leakage
Codman & Shurtleff is recalling Lumbar Drainage Catheter Kits because tubing may leak or disconnect, risking improper drainage or air entry.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as a Class II recall involving a medical device with a defect that can lead to significant physiological harm, such as pneumocephalus or improper CSF drainage, which aligns with the 'Severe' criteria for significant injury risk.
Plain-English summary
Codman & Shurtleff, Inc. is recalling the Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System), Catalog Number 82-1738. The recall involves 1,145 units 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 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 units were distributed worldwide, including nationwide in the United States and internationally to numerous countries. The agency has classified this as a Class II recall. Healthcare providers and patients should contact Codman & Shurtleff, Inc. for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Codman Lumbar Drainage Catheter Kit II with EDS 3 (External Drainage System) Catalog Number: 82-1738 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
- 1,145
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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