Reported Feb 17, 2021 · Terminated

EMBLEM S-ICD Model A209

Boston Scientific Corporation

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Boston Scientific Corporation · 4100 Hamline Ave N Bldg 3 · Saint Paul, MN · 55112-5700

Is this the product you have?

  • EMBLEM S-ICD Model A209
Lot codes and dates
  • Serial numbers

    1,953 of 1,953 codes

    • 104254
    • 104259
    • 104277
    • 104292
    • 104299
    • 104304
    • 104305
    • 104307
    • 104310
    • 104322
    • 104331
    • 104339
    • 104340
    • 104341
    • 104348
    • 104349
    • 104351
    • 104355
    • 104356
    • 104357
    • 104365
    • 104430
    • 104440
    • 104562
    • 104736
    • 104778
    • 104812
    • 104813
    • 104816
    • 104879
    • 104892
    • 104905
    • 104906
    • 104914
    • 104915
    • 104920
    • 104926
    • 104931
    • 104934
    • 104935
    • 104938
    • 104939
    • 104943
    • 104946
    • 104947
    • 104964
    • 104967
    • 104970
    • 104972
    • 104988
    • 104989
    • 104991
    • 104995
    • 104999
    • 105014
    • 105016
    • 105018
    • 105019
    • 105020
    • 105021
Amount recalled
1953 units

This recall covers 2 products

The agency filed one notice per product. You are reading one of them; the other one is below.

Why it was recalled

Stop using this product now

Electrical overstress may lead to device malfunction.

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 23, 2022 · Data as of Sep 19, 5:44 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.