Natus Manufacturing Limited Ida Business Park Glenbrack Road Galway Ireland Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining cerebrospinal fluid (CFS) from the cerebral ventricles or the lumbar subarachnoid space as a means of reducing intracranial pressure and CSF volume when the insertion of a permanent, internal shunt is not indicated.
Brand
Natus Manufacturing Limited Ida Business Park Glenbrack Road Galway Ireland
Lot Codes / Batch Numbers
Lot # 118000422298
Products Sold
Lot # 118000422298
Natus Manufacturing Limited Ida Business Park Glenbrack Road Galway Ireland is recalling Ref: NT821731C, Natus EDS 3 CSF External Drainage System - Product Usage: indicated for draining ce due to The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The external drainage system failed to meet Pyrogen test requirements for devices contacting cerebrospinal fluid of 2.15 endotoxins.
Recommended Action
Per FDA guidance
On January 12, 2021, Natus sent an "Urgent Field Safety Notice - Recall" notification to all affected consignees via US Mail. In addition to informing consignees about the recall, the notification asked consignees to take the following actions: 1. Please return these affected items at your earliest convenience to the following address: 3150 Pleasant View Road, Middleton, WI 53562 USA 2. Replacement product is available. The Technical Service department will be in contact in relation to the provision of the replacement product. 3. Please complete and return the customer reply form to Natus at the following Email address: FCA@Natus.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026