Recall Z-0680-2021— Boston Scientific Corporation

Name: FDA recall Z-0680-2021
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. It names one FDA 510(k) clearance: K051052. Product: IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿. 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

510(k) clearances named in this recall

1 on FDA's record

K051052 — SEEDNET FAMILY (SEEDNET/SEEDGOLD SYSTEM, CRYOTHERA SYSTEM, CRYO-HIT SYSTEM)Galil Medical , Ltd.·cleared 2005-05-06

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

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Reason for recall

Complaint trend regarding needle shaft gas leaks.

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