Product Wiki · Recalls · Health Canada — Medical Devices

Riata Products — recall 25758

Health Canada — Medical Devices · Canada · 2012-01-09 · Type II

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Agency: Health Canada — Medical Devices
Recall identifier: 25758
Date of alert: 2012-01-09
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: Riata and Riata ST silicone leads have demonstrated a high rate of externalized conductors, i.e. interior, ethylene tetrafluoroethylene (ETFE) covered, lead conductor wires extruding from the device lumen into the intravascular space.

Primary source: https://recalls-rappels.canada.ca/en/alert-recall/riata-products

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Riata Products — recall 25758

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