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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86776

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

Open FDA event record

Event summary

Timeline bucket
November 12, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
LivaNova USA Inc

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

VNS Therapy SENTIVA DUO # 1000-D - Product Usage: indicated for the treatment of chronic or recurrent depression in patients who are experiencing a treatment-resistant or treatment- intolerant depressive episode.

Z-0535-2021
Recall number
Z-0535-2021
Initiated
November 12, 2020
Classification
Class II
Status
Terminated
Recalling firm
LivaNova USA Inc
Quantity
8 generators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

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

During internal testing, it was found that upon a device reset, the Generator exhibits the incorrect Model Number when interrogated.

Code information

Model Number - Model 1000-D Serial Numbers: 311298 310443 310068 310353 310531 310351 310380 310348

Distribution pattern

International distribution in the countries of Austria and United Kingdom.