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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92798

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

Open FDA event record

Event summary

Timeline bucket
July 17, 2020
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.

Z-2657-2023
Recall number
Z-2657-2023
Initiated
July 17, 2020
Classification
Class II
Status
Terminated
Recalling firm
Medtronic Neuromodulation
Quantity
2,408 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
issue with some legacy clinician programmer software

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

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

Code information

Version 1.0.4232, UDI-DI 00763000273668.

Distribution pattern

Worldwide distribution - US Nationwide (there was government and military distribution) and the countries of Australia and Singapore.