PlainRecalls
FDA Devices Moderate Class II Completed

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Reported: December 30, 2020 Initiated: November 18, 2020 #Z-0682-2021

Product Description

IceFORCE" 2.1 CX Prostate Cryoablation Kit

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Details

Units Affected
85 units
Distribution
Nationwide
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
IceFORCE" 2.1 CX Prostate Cryoablation Kit. Recalled by Boston Scientific Corporation. Units affected: 85 units.
Why was this product recalled?
Complaint trend regarding needle shaft gas leaks.
Which agency issued this recall?
This recall was issued by the FDA Devices on December 30, 2020. Severity: Moderate. Recall number: Z-0682-2021.