Product Wiki · Recalls · Health Canada — Medical Devices

Imager II Angiographic Catheters - 5F Curved Tip Shapes (2020-08-04) — recall 61741

Health Canada — Medical Devices · Canada · 2020-10-09 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
61741
Date of alert
2020-10-09
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: We have identified an increase in the rate of tip detachment complaints on the 5F curve tip shapes configuration. Investigation has now concluded the need to expand the scope to all lots/batches of the 5F curved tip shapes of the Imager II Angiographic Catheters. There have been three patient injuries reported since the initial removal of product earlier this year.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/imager-ii-angiographic-cathete

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