Z-1921-2014Class I

Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914...

Name: Z-1921-2014 Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914...
Creator: Medtronic Neurosurgery
Published: 2014-06-09
License: https://open.fda.gov/license/

Medtronic Neurosurgery / initiated 2014-06-09 / Terminated / root cause: design

FDA source

Medtronic Neurosurgery began a recall of Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of... on 2014-06-09. FDA classified it as Class I and gives the reason as "Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1921-2014
Classification: Class I
Status: Terminated
Initiated: 2014-06-09
Posted: 2014-06-27
Terminated: 2015-01-14
Recalling firm: Medtronic Neurosurgery
Product: Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Catalog No. 46914. Intended to allow drainage and measurement of cerebrospinal fluid (CSF) and other fluids of similar physical character from the ventricles or the lumbar subarachnoid (intrathecal) region.
Product code: JXG Shunt, Central Nervous System And Components
Reason for recall: Medtronic Neurosurgery is recalling the Medtronic Duet External Drainage and Monitoring Systems because the patient line tubing in the Duet External Drainage and Monitoring Systems may become disconnected from the patient line stopcock.
Root cause tag: design
FDA root cause: Device Design
Action: An Urgent Medical Device Recall letter, dated 6/9/14, was sent to all their customers who purchased the Medtronic Duet External Drainage and Monitoring Systems. The letter informs the customers of the problem identified and the actions to be taken. Customers are instructed to cease use of the affected product, return any used units, account for any product used and verify that connections are in the condition as stated in the Instructions for Use for product currently in use. Additionally, customers are to complete the Customer Product Accountability Form. Customers with questions about the recall letter are instructed to contact Bob Shokoohi at (805) 571-8725.
Quantity in commerce: 5,744 units
Distribution: Worldwide Distribution -- USA, Australia, Belgium, Canada, Croatia, Cyprus, Denmark, Egypt, Finland, France, Greece, Iran, Israel, Italy, Kuwait, Netherlands, Norway, Poland, Puerto Rico, Romania, Russian Federation, Saudi Arabia, Singapore, South Africa, Switzerland, Turkey, and United Kingdom.
Product codes and lots: Lot No. 206843112 206854300 206875578 206923218 206951123 206962974 206986677 207167084 207246210 207312741 207441171 207466011 207466012 207560684 207632971 207659577 207716835 207716836 207766493 207900255 207945036 207983301 208008802

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1921-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1920-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1921-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1922-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1923-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27
Z-1924-2014	Class I	Terminated	Voluntary: Firm initiated	2014-07-09	2014-06-27

Product code JXG

K984053Class IIBecker External Drainage and Monitoring SystemMedtronic PS Medical / cleared 1999-02-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)