The Medtronic StrataMR adjustable valves and shunts are designed to provide continuous cerebrospinal fluid (CSF) flow fr

FDA device recall Z-1702-2017 · posted 2017-04-07 · Terminated

Recall details

Recalling firm

Medtronic Neurosurgery

Reason for recall

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.

Action taken

The firm has initiated a CAPA and issued notification via letter to US Customers on February 22, 2017. As of the date of the report (2/22/17) the firm was still in process of notifying foreign customers. Recipients are instructed to: 1) Cease use of the listed product, 2) Account for number of product units implanted or discarded and return any unused units by completing an attached individualized customer product accountability form provided in the letter, 3) If any of the indicated products have been implanted in patients, to adjust the valves according to instructions listed in an included attachment. Recipients are asked to fax a customer acknowledgment response form or scan/take a picture of the form and email to rs.mnsfca@medtronic.com with "StrataMR Recall" in the subject line.

Root cause

Device Design

Status

Terminated

Product code

JXG

Quantity affected

2622 units (US = 1796, outside US =826)

Distribution

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

Date initiated

2017-02-22

Date posted

2017-04-07

Date terminated

2017-09-19

Location

Goleta, CA

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