Exalt Model D Single-Use Duodenoscope
Brand(s)
Summary
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
Boston Scientific Corporation
300 Boston Scientific Way, Marlborough, Massachusetts
United States, 01752
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