Reported Jan 8, 2025 · Ongoing

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL…

Medtronic Neuromodulation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Medtronic Neuromodulation · 7000 Central Ave Ne · Minneapolis, MN · 55432-3568

Is this the product you have?

  • SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900E CLINICIAN TABLET GLBL SMSNG and PROG CT900E CLINICIAN TABLET PAPER EN with the A810 CP app version 2.x, CFN CT900E
Lot codes and dates
  • GTIN00763000447090 00763000729141 00763000737290 00763000447090
  • Serial Numbers

    2,956 of 2,956 codes

    • NPL3020725
    • NPL3021958
    • NPL3021963
    • NPL3021966
    • NPL3021969
    • NPL3021970
    • NPL3021971
    • NPL3021974
    • NPL3021983
    • NPL3021984
    • NPL3021990
    • NPL3021997
    • NPL3022002
    • NPL3022005
    • NPL3022014
    • NPL3022022
    • NPL3022031
    • NPL3022032
    • NPL3022038
    • NPL3022044
    • NPL3022052
    • NPL3022062
    • NPL3022069
    • NPL3022070
    • NPL3022071
    • NPL3022072
    • NPL3022073
    • NPL3022074
    • NPL3022109
    • NPL3022114
    • NPL3022118
    • NPL3022124
    • NPL3022125
    • NPL3022131
    • NPL3022139
    • NPL3022187
    • NPL3022190
    • NPL3022193
    • NPL3022194
    • NPL3022195
    • NPL3022212
    • NPL3022213
    • NPL3022216
    • NPL3022218
    • NPL3022245
    • NPL3022257
    • NPL3022278
    • NPL3022280
    • NPL3022289
    • NPL3022291
    • NPL3022304
    • NPL3022311
    • NPL3022313
    • NPL3022314
    • NPL3022328
    • NPL3022352
    • NPL3022357
    • NPL3022364
    • NPL3022365
    • NPL3022711
    N
Amount recalled
3981 systems

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

Why it was recalled

Software issues were identified in application version 2.x.

This product could cause temporary or reversible health problems — stop using it.

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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:52 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.