The Recall Desk

FDA (Devices) recall action 89931

Boston Scientific Corporation recalled 4 products on 2022-05-25

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2022-05-25
Critical
0
Units
1,632

Why these products were recalled

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.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–4 of 4

  • ModerateFDA (Devices)··2022-05-25

    EXALT Model D Single-Use Duodenoscope Updated Guidance on Perforation Risk

    Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 2) UPN: M00542421 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
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-05-25

    FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk

    Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2022-05-25

    EXALT Model D Duodenoscope Updated Instructions Address Known Perforation Risk

    Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.

    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 s
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2022-05-25

    EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk

    Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 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
    Category
    Distribution
    0 states