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FDA announces Class I recall of Medtronic neurosurgery product

The FDA announced the Class I recall of the Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System in a press release and noted the system’s patient line tubing may separate from the patient line connectors, causing product failure or patient injury.

Any tubing disconnection may result in air within the skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the cerebrospinal fluid that may contribute to serious adverse health consequences, including death, according to the release.
The recall was initiated June 9 when Medtronic Neurosurgery sent an Urgent Medical Device Recall letter to customers to identify the products affected, the problem and action to be taken.

Medtronic has not received reported of any deaths related to these products.

The affected products were manufactured from March 15, 2013 through Feb. 28, 2014 and distributed from April 10, 2013 through May 19, 2014.

The products being recalled are as follows:

• Interlink Injection Sites, Catalog Number 46913;

• SmartSite Injection Sites, Catalog Number 46914;

• Interlink Injection Sites, Ventricular, Catheter, Catalog Number 46915;

• SmartSite Injection Sites, Ventricular Catheter, Catalog Number 46916; and

• Interlink Injection Sites, Lumbar Catheter, Catalog Number 46917.

For list of all the affected lots numbers and more information on the recall please visit http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm403857.htm