Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

EMBLEM MRI S-ICD Model A219 Recalled by Boston Scientific Corporation Due to Electrical overstress may lead to device malfunction.

Date: December 2, 2020
Company: Boston Scientific Corporation
Status: Terminated
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

EMBLEM MRI S-ICD Model A219

Quantity: 872 units

Why Was This Recalled?

Electrical overstress may lead to device malfunction.

Where Was This Sold?

Distribution throughout United States and worldwide. Foreign distribution was made to Canada and other countries.

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