Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury

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
Interlink Injection Sites, Lumbar Catheter, Catalog Number 46917

[Posted 07/02/2014]

AUDIENCE: Neurology, Nursing, Risk Manager, Surgery

ISSUE: FDA notified healthcare professionals of a Class I recall of Medtronic Duet External Drainage and Monitoring System. The firm recalled the device because the patient line tubing may separate from the patient line connectors. According to the firm, the patient line is more likely to disconnect during frequent handling, such as connections where injections or sampling may frequently occur.

The device failure may result in air within the skull (pneumocephalus), infection (such as meningitis, ventriculitis, encephalitis) and over/under drainage of the CSF that may contribute to serious adverse health consequences, including death. The firm has not received any reports of deaths.

BACKGROUND: The Medtronic Duet External Drainage and Monitoring System (EDMS) externally drains and monitors cerebrospinal fluid (CSF) and monitors intracranial pressure (ICP). The device is intended to be used only when trained personnel are present to supervise monitoring and drainage 24-hours a day.

The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014. See the recall notice for a listing of the affected lot numbers.

RECOMMENDATION: On June 9, 2014, the firm sent an Urgent Medical Device Recall letter to their customers. The letter identified the product, the problem, and the actions to be taken. The firm requested customers to:

• Stop using the affected product and return all unused devices to Medtronic Neurosurgery.
• Complete and return the Customer Product Accountability Form enclosed with the letter.
• If affected products are in use, verify all connections are secure and leak-free per the Instructions for Use.

For questions about this recall, customers may contact the firm’s Director of Quality at 1-805- 571-8725, Monday - Friday, 8:00 a.m. - 5:00 p.m., Pacific Time.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/02/2014 - Recall Notice - FDA]