Product Wiki · Recalls · Health Canada — Medical Devices

Emerge Monorail PTCA Dilatation Catheter & NC Emerge PTCA Dilatation… — recall 47945

Health Canada — Medical Devices · Canada · 2019-11-22 · Type II

As described by Health Canada — Medical Devices: Emerge Monorail PTCA Dilatation Catheter & NC Emerge PTCA Dilatation Catheter (2019-10-28)

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
Health Canada — Medical Devices
Recall identifier
47945
Date of alert
2019-11-22
Country / jurisdiction
Canada
Risk level
Type II
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Reported risk: Voluntary removal of certain dilation and extension catheters. Specific batches of these catheters may have missed the hydrophilic coating step, which creates a lubricious surface on the devices, during the manufacturing process.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/emerge-monorail-ptca-dilatatio

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