Recall Z-0659-2021— Boston Scientific Corporation

Name: FDA recall Z-0659-2021
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: K162599. Product: IceFORCE" 2.1 CX L 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

K162599 — IcePearl 2.1 CX L, IceForce 2.1 CX LGalil Medical , Ltd.·cleared 2016-10-11

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

IceFORCE" 2.1 CX L 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.