Medtronic Neurosurgery recalls The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow f…

Recall date

February 22, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1702-2017

FDA classification

Class I

Brand / firm

Medtronic Neurosurgery

Sold / distributed

Product was distributed throughout the US and to Australia, Belgium, Canada, Finland, Germany, Hong Kong, Israel, Italy, Japan, New Zealand, Norway, Poland, Portugal, the Russian Federation, Singapore, Spain, Sweden, Switzerland, Turkey, and the UK.

Why it was recalled

Incorrect valve rotor orientation due to misalignment and/or off-center positioning of the StrataMR Locator Tool: When the StrataMR valve is set in the incorrect orientation, higher valve opening pressures result leading to a corresponding underdrainage in CSF fluid performance. This condition may result in the following adverse health consequences: ventriculomegaly, headaches, nausea, vomiting and lethargy. If left untreated, underdrainage has the potential to lead to coma and death.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to non-invasive adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation. After surgical implantation, the Medtronic Neurosurgery StrataMR valves provide a non-invasive method to address changing patient needs in the management of hydrocephalus. The valve design enables the physician to adjust the valve pressure/performance level using the Medtronic StrataMR Adjustment Tools. The StrataMR valves are intended to maintain performance level setting under magnetic resonance imaging (MRI) exposure when scanned in accordance with the MRI conditions in the labeling. The StrataMR valves, small and regular, provide the full range of performance levels: 0.5, 1.0, 1.5, 2.0, and 2.5. The currently set performance level is discernible through use of the Indicator Tool or by x-ray (for corresponding settings, refer to figure 6). The dome is designed to allow needle puncture via a 25-gauge or smaller noncoring needle. The StrataMR valve can be flushed in either the distal or proximal direction by percutaneous finger pressure. Occluders are located proximally and distally to the central reservoir on the StrataMR valve regular and only distally on the small model to facilitate selective flushing.