Product Wiki · Recalls · Health Canada — Medical Devices

Strata Valves (2017-03-13) — recall 56994

Health Canada — Medical Devices · Canada · 2017-03-31 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
56994
Date of alert
2017-03-31
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: The adjustable mechanism in the Strata device allows the physician to non-invasively adjust the valve's pressure/performance level using a magnetic adjustment tool included with the strata adjustment kit or with the Stratavarius System. Accumulation of biological debris within the valve adjustment mechanism may inhibit the free rotation of the valve magnet when exposed to 3T MRI and may become reverse polarised. This may result in discrepancies between the pressure level readings on the strata indicator tool or Stratavarius System.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/strata-valves-2017-03-13

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