Skip to content

Medtronic Duet External Drainage and Monitoring System… recallZ-1923-2014 · Medtronic Neurosurgery · initiated Jun 9, 2014

Class I Terminated All recalls posted in June 2014

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Medtronic Neurosurgery or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Device Design

What the company is doing

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.

Recall details

Recall number
Z-1923-2014
Recall class
Class I (most serious)
Status
Terminated
Initiated by the company
Jun 9, 2014
Posted by the FDA
Jun 27, 2014
Recalling firm
Medtronic Neurosurgery
Quantity
1,187 units
Product code
JXG
FDA submissions
K984053
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 description

Medtronic Duet External Drainage and Monitoring System, SmartSite Injection Sites, Ventricular Catheter, Catalog No. 46916. 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.

Code information (models, lots, serial numbers)

Lot No.  206843114 206854302 206923345 207167085 207246211 207466015 207565607 207716842 207766492 208031202

Other devices under the same FDA submission

33 devices cleared under K984053 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 68503).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page