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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82626

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

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Event summary

Timeline bucket
May 15, 2019
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.

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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

InterStim(TM) System, Model Numbers: a) TH90G01 b) TH90GFA c) TH90G02 d) TH90G03 Product Usage: The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStim neurostimulators for sacral neuromodulation therapy. The clinician uses the Clinician app to program settings for the patient. The A510 Clinician app, HH90 Handset, TM90 Communicator along with the A520 Patient app are only sold as a kit (TH90).

Z-1774-2019
Recall number
Z-1774-2019
Initiated
May 15, 2019
Classification
Class II
Status
Ongoing
Recalling firm
Medtronic Neuromodulation
Quantity
13979 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

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Inspect official wording and provenance

Reason for recall

There is a potential for an unexpected increase in stimulation during InterStim programming with the A10 Clinician Application (on Medtronic's smart programmer).

Code information

Model Numbers/UDI: a) TH90G01/00763000058005 b) TH90GFA/00763000187231 c) TH90G02/00763000192259, 00763000192266, 00763000192273, 00763000192280, 00763000192297, 00763000192303, 00763000192310 d) TH90G03/00763000192310 ALL LOT/SERIAL NUMBERS

Distribution pattern

Worldwide Distribution - US Nationwide & PR, and Germany, Switzerland, Italy, Spain, France, UK, Norway, Denmark, Finland, Netherlands