StrataMR Valve (2017-03-06)

Starting date:

March 6, 2017

Posting date:

March 16, 2017

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-62678

• Reason
• Affected products

Reason

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.

Affected products