PlainRecalls
FDA Devices Moderate Class II Completed

IceRod" 1.5 MRI Cryoablation Needle¿

Reported: December 30, 2020 Initiated: November 18, 2020 #Z-0679-2021

Product Description

IceRod" 1.5 MRI Cryoablation Needle¿

Reason for Recall

Complaint trend regarding needle shaft gas leaks.

Details

Units Affected
772 units
Distribution
Nationwide
Location
Maple Grove, MN

Frequently Asked Questions

What product was recalled?
IceRod" 1.5 MRI Cryoablation Needle¿. Recalled by Boston Scientific Corporation. Units affected: 772 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-0679-2021.