Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Completed

IceSphere" 1.5 90 Cryoablation Needle

FDA Recall Z-0673-2021 · Posted None

Recalling FirmBoston Scientific Corporation
Recall StatusCompleted
Product CodeGEH
Date Initiated2020-11-18
Product Quantity92 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.

K060390SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERAGalil Medical , Ltd. · 2006-04-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑