PlainRecalls
FDA Devices Moderate Class II Completed

IceSphere" 1.5 CX 90¿ Cryoablation Needle

Reported: December 30, 2020 Initiated: November 18, 2020 #Z-0664-2021

Product Description

IceSphere" 1.5 CX 90¿ Cryoablation Needle

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Details

Units Affected
6,363 units
Distribution
Nationwide
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
IceSphere" 1.5 CX 90¿ Cryoablation Needle. Recalled by Boston Scientific Corporation. Units affected: 6,363 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-0664-2021.