Recall Z-1702-2017 ยท JXG Shunt, Central Nervous System And Components
Medtronic Neurosurgery
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 con
| Date | Apr 7, 2017 (initiated Feb 22, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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 inc |
| Quantity | 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, Spain, Sweden, Switzerland, Turkey, and the UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K152700 | StrataMR Valves and Shunts Medtronic Neurosurgery, Apr 7, 2016 |