Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement,…
Updated Instructions for Use (IFU) for EXALT Model D Single-Use Duodenoscope highlight the known risk of perforation and provide best clinical practices related to insertion, advancement,…
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that…
Users need to be aware that embolism is a possible adverse event associated with hydrogel misplacements. Updated IFU provides new procedural instructions, warnings and precautions that…
Sterility of device is compromised due to a sterile barrier breach
Class IIFDA: OngoingBoston Scientific Corporation
Understanding this recall history
This page summarizes recall records in which the official source identifies Boston Scientific Corporation as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.