Exact FDA event identifier

Event 69844

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

Open FDA event record

Event summary

Timeline bucket: November 20, 2014
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 VNS Therapy AspireHC, Model 105 Generator. The Cyberonics VNS Therapy System consists of the implantable VNS Therapy Generator, the VNS Therapy Lead, and the external programming system used to change the stimulation settings. Indicated for use as an adjunctive therapy in reducing the frequency of seizures.

Z-0858-2015

Recall number: Z-0858-2015
Initiated: November 20, 2014
Classification: Class II
Status: Terminated
Recalling firm: Cyberonics, Inc
Quantity: 1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The recalled product was distributed with an incorrect serial number printed on the device's label.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The recalled product was distributed with an incorrect serial number printed on the device's label.

Code information

Serial Number: 31309; UDI: (01)05425025750054(11)140917(17)160808(21)31309(99)10-0009-5705.

Distribution pattern

Distributed to PA.