Recall Z-0690-2021— Boston Scientific Corporation

Name: FDA recall Z-0690-2021
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 IceRod" i-Thaw" 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 IceRod" i-Thaw" 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.