FDA-Device2020-12-30Class II

IceSeed" Prostate Cryoablation Kit

Boston Scientific Corporation
Hazard

Complaint trend regarding needle shaft gas leaks.

Sold states
Nationwide
Affected count
211 units
Manufactured in
1 Scimed Pl, N/A, Maple Grove, MN, United States
Products
IceSeed" Prostate Cryoablation Kit

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0692-2021

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