Exalt Model D Single-Use Duodenoscope
Brand(s)
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: 2022-03-17
Alert / recall type
Health product recall
Category
Health product - Medical device - 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