Recall Class: Class I
Date Recall Initiated: June 9, 2014
Products: Medtronic Duet External Drainage and Monitoring System
- 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
See Affected Lot Numbers below.
The affected products were manufactured from March 15, 2013 through February 28, 2014 and distributed from April 10, 2013 through May 19, 2014.
Use: 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.
125 Cremon Drive
Goleata, California 93117
Paseo del Cucapah
22210 Tijuana, Baja California
Reason for Recall: 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.
Public Contact: 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.
FDA District: Los Angeles District Office
More Information about this Recall:
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.
Catalog# 46913: 206923217, 207096627, 207096630, 207187691, 207224897, 207269986, 207466017, 207565424, 207565425, 207659575, 207659576, 207739874, 207875274, 207945037, 207982847
Catalog# 46914: 206843112, 206854300, 206875578, 206923218, 206951123, 206962974, 206986677, 207167084, 207246210, 207312741, 207441171, 207466011, 207466012, 207560684, 207632971, 207659577, 207716835, 207716836, 207766493, 207900255, 207945036, 207983301, 208008802
Catalog# 46915: 206923344, 206986678, 207096628, 207565426, 207659574, 207945035, 207982846, 208031201, 208055143
Catalog# 46916: 206843114, 206854302, 206923345, 207167085, 207246211, 207466015, 207565607, 207716842, 207766492, 208031202
Catalog# 46917: 208031203
About Class I Recalls:
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.