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Health Canada Medical devices

Exalt Model D Single-Use Duodenoscope

Issued October 18, 2023
Issue
Boston Scientific Corporation (BSC) is initiating a removal of specific batches of Exalt Model D Single-Use Duodenoscopes that were manufactured with an alternate imager configuration. BSC has received an increase in complaints for poor quality image due to fluid ingress in the lens. Recall Start Date: October 3, 2023
Hazard description
Performance
Product
Product name
Exalt Model D Single-Use Duodenoscope
Reference
ID
RA-74439