IceSeed" 1.5 MRI 90 Cryoablation Needle
FDA Recall Z-0680-2021 · Posted None
Recalling FirmBoston Scientific Corporation
Recall StatusCompleted
Product CodeGEH
Date Initiated2020-11-18
Product Quantity1,526 units
Reason for Recall
Complaint trend regarding needle shaft gas leaks.
Firm Action
Customers will be sent a product advisory via overnight mail.
Root Cause
Under Investigation by firm
Distribution Pattern
Nationwide
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.