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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84710

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

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Event summary

Timeline bucket
August 13, 2019
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 Generator Model # 1000 Labeling 26-0009-6800 Model 1000 Generator Sample Labels 26-0009-9600 Patient s Manual for Depression 26-0009-9500 Patient s Manual for Epilepsy 76-0000-5000 VNS Therapy System Physician s Manual (refer to Attachment 1)

Z-1118-2020
Recall number
Z-1118-2020
Initiated
August 13, 2019
Classification
Class II
Status
Terminated
Recalling firm
LivaNova USA Inc
Quantity
6 generators

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Firm identified a subset of its generators that were sterilized one additional sterilization cycle, which does not meet the firm's quality specifications.

Code information

Model Serial No. UDI Model 1000 204460 01054250257504051119080317201205212044609910-0011-6102 Model 1000 183960 01054250257504051119080217200912211839609910-0011-6102 Model 1000 194980 01054250257504051119080217201030211949809910-0011-6102 Model 1000 204700 01054250257504051119080217201205212047009910-0011-6102 Model 1000 206720 01054250257504051119080317201219212067209910-0011-6102 Model 1000 213290 01054250257504051119080517210108212132909910-0011-6102

Distribution pattern

US: FL, GA, KS, MO, and UT. No OUS distribution