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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72698

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

Open FDA event record

Event summary

Timeline bucket
November 18, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Cyberonics, 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

Cyberonics Vagus Nerve Stimulator VNS Therapy AspireSR Generator, Model 106

Z-0645-2016
Recall number
Z-0645-2016
Initiated
November 18, 2015
Classification
Class II
Status
Terminated
Recalling firm
Cyberonics, Inc
Quantity
29 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Manufacturing material removal

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Certain Model 106 Pulse Generators demonstrate delays in sensing during use of the 'Verify Heartbeat Detection' feature and exhibit the potential for decreased battery longevity.

Code information

Serial numbers 36602, 37019, 39097, 40311, 40465

Distribution pattern

US Distributions to the states of : IL, NC, KS, and TX., and Internationally to the country of: United Kingdom.