medical Class II Updated 2022-05-25

Boston Scientific Corporation recalls EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242C

Recalled Product

EXALT Model D Single-Use Duodenoscope (Box 1) UPN:M0054242CE0 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic surgery.

Hazard / Issue

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, and removal of this device.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: All lots GTIN: 08714729995746
View official government recall

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