Product Wiki · Recalls · Health Canada — Medical Devices

PentaRay High Density Catheters (2016-04-15) — recall 55328

Health Canada — Medical Devices · Canada · 2016-04-29 · Type II

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Agency
Health Canada — Medical Devices
Recall identifier
55328
Date of alert
2016-04-29
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: Biosense Webster is clarifying the contraindication language in the instructions for use (IFU) and product labeling relative to patients with prosthetic valves. The current language states: "[The] use of this catheter may not be appropriate for use in patients with prosthetic valves." Biosense Webster is updating the IFU to clarify the contraindication statement as follows: "do not use PentaRay catheters in patients with prosthetic valves." this action is not a product removal.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/pentaray-high-density-catheter

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