Product Wiki · Recalls · Health Canada — Medical Devices

Optease Retrievable Vena Cava Filter (2013-10-07) — recall 50119

Health Canada — Medical Devices · Canada · 2013-10-31 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
50119
Date of alert
2013-10-31
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Cordis has identified a printing error on one unit of Optease Vena Cava filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring an additional percutaneous procedure to retrieve the filter. All unexpired distributed lots of the Cordis Optease Vena Cava filter are being removed, since it cannot be absolutely determined that no other similar printing errors occurred. This recall is separate from the correction letter of April 3, 2013 (Recall number 83564).
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/optease-retrievable-vena-cava-

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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