CLASS I Device recall · Reported 27 Jan 2021 · FDA Enforcement Report

Emblem S-icd Subcutaneous Electrode recalled by Boston Scientific

Boston Scientific is recalling Emblem S-icd Subcutaneous Electrode. The recall was initiated on 13 Nov 2020 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesAll serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Quantity recalled47000 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0879-2021
FDA event ID: 87014
Recalling firm: Boston Scientific, Saint Paul, MN
Classification: Class I
Status: Terminated
Recall initiated: 13 Nov 2020
FDA classified: 19 Jan 2021
Reported: 27 Jan 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Pacemakers & Defibrillators

Timeline

13 Nov 2020	Recall initiated by company
19 Jan 2021	Classified by FDA	+67 days
27 Jan 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is potential for fractures which results in the inability to delivery therapy.

Product as listed by the FDA

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Where it was distributed

Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

Questions about this recall

Is Emblem S-icd Subcutaneous Electrode recalled?

Yes. Boston Scientific recalled Emblem S-icd Subcutaneous Electrode on 13 Nov 2020. The recall is Class I and its status is Terminated. Recall number Z-0879-2021.

Why was it recalled?

There is potential for fractures which results in the inability to delivery therapy.

Which lots are affected?

All serialized EMBLEM Subcutaneous Electrodes Model 3501 manufactured and distributed are subject to this worldwide advisory communication.

Where was it sold?

Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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