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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87014

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
November 13, 2020
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Boston Scientific Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-0879-2021
Recall number
Z-0879-2021
Initiated
November 13, 2020
Classification
Class I
Status
Terminated
Quantity
47000 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is potential for fractures which results in the inability to delivery therapy.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

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