Recall Z-2681-2020— Boston Scientific Corporation

Name: FDA recall Z-2681-2020
Creator: U.S. Food and Drug Administration
Published: 2020-06-04

Class II · Terminated

Class II FDA medical device recall by Boston Scientific Corporation, initiated 2020-06-04, terminated 2024-09-23. It names one FDA 510(k) clearance: K152133. Product: Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.. Reason: The needle surface deteriorated due to unexpected electrolysis during procedure..

Recalling firm: Boston Scientific Corporation
Classification: Class II
Status: Terminated
Initiated: 2020-06-04
Terminated: 2024-09-23
Firm location: Marlborough, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K152133 — IcePearl 2.1 CX Cryoablation Needle, IcePearl 2.1 CX Prostate Cryoablation Kit Visual-ICE System, IceFORCE 2.1 CX Cryoablation Needle, IceFORCE 2.1 CX Prostate Cryoablation Kit Visual-ICE SystemGalil Medical , Ltd.·cleared 2015-08-28

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

Ablation Galil Technology, Three IceFORCE 2.1 Prostate Cyroablation Kit Visual ICE System, Prescription Only Galil Medicals 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures.

Reason for recall

The needle surface deteriorated due to unexpected electrolysis during procedure.

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