Product Wiki · Recalls · Health Canada — Medical Devices

Strata II, Delta, and CSF-Flow Control Valves and Shunts (2021-01-18) — recall 62057

Health Canada — Medical Devices · Canada · 2021-02-05 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
62057
Date of alert
2021-02-05
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Potential for variation in radiopaque marking visibility under radiographic imaging for Medtronic adjustable and fixed-pressure valves that are used in the management of hydrocephalus. This issue does not impact the therapeutic pressure performance of these devices, however variation in radiopaque marking visibility post-implant may limit the ability to determine pressure settings and flow direction with radiographic imaging.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/strata-ii-delta-and-csf-flow-c

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