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Health Canada Medical devices

Exalt Model D Single-Use Duodenoscope

Issued March 14, 2022
Issue
Due to the higher observed occurrence of esophageal perforations compared to the rate reported in literature, a product advisory is recommended to make users aware of the events and to reiterate and supplement the warnings and directions related to perforations in the product labeling, and to communicate the intent to update the instructions for use with this information. Recall start date: Mar 3, 2022
Hazard description
Revised instructions for use
Product
Product name
Exalt Model D Single-Use Duodenoscope
Reference
ID
RA-63991