StrataMR Adjustment Tools and StrataMR Guider Tool (2018-10-25)

Starting date:

October 25, 2018

Posting date:

November 28, 2018

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-68394

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  Reason
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  Affected products

Affected products

1. StrataMR Adjustment Tools
2. StrataMR Guider Tool

Reason

Medtronic is initiating a voluntary correction because there is a modification to the StrataMR Adjustment Tool Set which adds a fourth component, the Guider Tool, in order to improve users' ability to reliably adjust StrataMR valves and mitigate the potential of valve rotor foot being positioned on top of an MRI Resistance Wall, which has the potential of causing a higher than intended flow resistance. There is no change to the design of the existing three tools of the StrataMR adjustment tool sets. The StrataMR valves and shunts have been removed from the market as of February 2017; therefore this correction is intended for use with patients who currently have the StrataMR valves implanted.

Affected products