Recall Z-0671-2021— Boston Scientific Corporation

Name: FDA recall Z-0671-2021
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: K141485. Product: IceSphere" 1.5 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

K141485 — ICESPHERE 1.5 90 CRYOBLATION NEEDLE, ICESHPERE 1.5 CYOBLATION NEEDLEGalil Medical , Ltd.·cleared 2014-07-02

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

IceSphere" 1.5 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.