Exalt Model D Single-Use Duodenoscope
Brand(s)
Last updated
Summary
Product
Exalt Model D Single-Use Duodenoscope
Issue
Medical devices - Performance issue
What to do
Contact the manufacturer if you require additional information.
Audience
Healthcare
Affected products
Affected Products |
Lot or serial number |
Model or catalog number |
|---|---|---|
Exalt Model D Single-Use Duodenoscope |
More than 50 numbers, contact manufacturer. |
M00542420 |
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
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
Healthcare
Recall class
Type II
Identification number
RA-74439
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