Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿ Recalled by Boston Scientific Corporation Due to Complaint trend regarding needle shaft gas leaks.

Date: November 18, 2020
Company: Boston Scientific Corporation
Status: Completed
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Boston Scientific Corporation directly.

Affected Products

IceSeed" 1.5¿ MRI 90¿ Cryoablation Needle ¿

Quantity: 1,526 units

Why Was This Recalled?

Complaint trend regarding needle shaft gas leaks.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Boston Scientific Corporation

Boston Scientific Corporation has 601 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report