Recall Z-0396-2024— Boston Scientific Corporation

Name: FDA recall Z-0396-2024
Creator: U.S. Food and Drug Administration
Published: 2023-09-27

Class II · Ongoing

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2023-09-27. It names one FDA 510(k) clearance: K193202. Product: EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.. Reason: Poor image quality due to fluid ingress in the lens..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Ongoing
Initiated: 2023-09-27
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: Outer box UPN# M00542420 & Outer box UPN# M0054242CE0.

Reason for recall

Poor image quality due to fluid ingress in the lens.

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