Recall Z-1082-2022— Boston Scientific Corporation

Name: FDA recall Z-1082-2022
Creator: U.S. Food and Drug Administration
Published: 2022-03-03

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2022-03-03. It names one FDA 510(k) clearance: K193202. 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 surgery.. Reason: 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..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2022-03-03
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K193202 — EXALT Model D Single-Use Duodenoscope, EXALT ControllerBoston Scientific Corporation·cleared 2019-12-13

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 surgery.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.