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[Recalled] EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209 — Accelerated battery depletion may result in a need for device replacement earli… | FDA 2020-12-02

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductEMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
Brand / manufacturerBoston Scientific Corporation
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0935-2021
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date02 December 2020

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Accelerated battery depletion may result in a need for device replacement earlier than expected.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Boston Scientific Corporation

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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