Recall Z-0689-2021— Boston Scientific Corporation

Name: FDA recall Z-0689-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-18

Class II · Completed

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-11-18. FDA's recall record names no specific 510(k) clearance for this event. Product: Five IceSphere" Prostate Cryoablation Kit. Reason: Complaint trend regarding needle shaft gas leaks..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Completed
Initiated: 2020-11-18
Firm location: Maple Grove, MN, United States

Product description

Five IceSphere" Prostate Cryoablation Kit

Reason for recall

Complaint trend regarding needle shaft gas leaks.

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