Product Wiki · Recalls · Health Canada — Medical Devices

StrataMR Valve (2017-03-06) — recall 56560

Health Canada — Medical Devices · Canada · 2017-03-16 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
56560
Date of alert
2017-03-16
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Medtronic is initiating this voluntary recall because the StrataMR Valve may experience a condition that may, in limited circumstances, affect the flow resistance in the valve and result in underdrainage of cerebrospinal fluid (CSF). The recall is based on an issue impact assessment, where an increase in the complaint rate related to incorrect flow was noted for the StrataMR product family which indicated that current residual risk for StrataMR products is undesirable and requires additional mitigations to reduce risk. This condition may result in the following adverse health consequences: headaches, nausea, vomiting and lethargy. If left untreated underdrainage has the potential to lead to coma and death.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/stratamr-valve-2017-03-06

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