Health product recall

Exalt Model D Single-Use Duodenoscope

Last updated

Summary

Product
Exalt Model D Single-Use Duodenoscope
Issue
Medical devices - Revised instructions for use
What to do

Contact the manufacturer if you require additional information.

Affected products

Affected Products Lot or Serial Number Model or catalog number
Exalt Model D Single-Use Duodenoscope All lots. M00542420, M00542421, M0054242CE0, M0054242CE1

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

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology & Urology
Companies

Boston Scientific Corporation

300 Boston Scientific Way, Marlborough, Massachusetts

United States, 01752

Published by
Health Canada
Audience
General public
Health professionals
Hospitals
Recall class
Type II
Identification number
RA-63991