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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98097

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

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Event summary

Timeline bucket
December 03, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medtronic Neuromodulation

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

A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).

Z-1043-2026
Recall number
Z-1043-2026
Initiated
December 03, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neuromodulation
Quantity
7123

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.

Code information

version 2.0.2465 and 2.0.2683 UDI-DI (GTIN) 00763000520083 Affected product is the software. Implanted Vanta Neurostimulator devices are not affected.

Distribution pattern

Worldwide - US Nationwide distribution.