Recall Z-0078-2018— Boston Scientific Corporation

Name: FDA recall Z-0078-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-04

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2017-10-04, terminated 2019-10-15. FDA's recall record names no specific 510(k) clearance for this event. Product: RESONATE EL ICD DR, Model D433, Sterile.. Reason: The devices have an incorrect firmware configuration..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-10-04
Terminated: 2019-10-15
Firm location: Saint Paul, MN, United States

Product description

RESONATE EL ICD DR, Model D433, Sterile.

Reason for recall

The devices have an incorrect firmware configuration.

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