Class II — Potential Health Hazard

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

EMBLEM S-ICD pulse generators Recalled by Boston Scientific Corporation Due to Accelerated battery depletion may result in a need...

Date: December 2, 2020
Company: Boston Scientific Corporation
Status: Ongoing
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 S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

Quantity: 7093 units

Why Was This Recalled?

Accelerated battery depletion may result in a need for device replacement earlier than expected.

Where Was This Sold?

worldwide

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