Reported Jan 8, 2025 · Ongoing

SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used with PROG CT900B CLINICIAN TABLET EU -UK…

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 CT900B CLINICIAN TABLET EU -UK with the A810 CP app version 2.x, CFN CT900B
Lot codes and dates
  • GTIN
    • 00643169890947
    • 00763000447090
  • Serial Numbers

    319 of 319 codes

    • NPL1000037
    • NPL1000042
    • NPL1000045
    • NPL1000048
    • NPL1000051
    • NPL1000054
    • NPL1000055
    • NPL1000056
    • NPL1000062
    • NPL1000069
    • NPL1000072
    • NPL1000073
    • NPL1000074
    • NPL1000075
    • NPL1000078
    • NPL1000083
    • NPL1000092
    • NPL1000093
    • NPL1000094
    • NPL1000096
    • NPL1000098
    • NPL1000132
    • NPL1000151
    • NPL1000159
    • NPL1000161
    • NPL1000165
    • NPL1000166
    • NPL1000173
    • NPL1000174
    • NPL1000179
    • NPL1000180
    • NPL1000185
    • NPL1000186
    • NPL1000189
    • NPL1000191
    • NPL1000195
    • NPL1000196
    • NPL1000230
    • NPL1000233
    • NPL1000238
    • NPL1000239
    • NPL1000249
    • NPL1000257
    • NPL1000281
    • NPL1000297
    • NPL1000301
    • NPL1000303
    • NPL1000321
    • NPL1000323
    • NPL1000325
    • NPL1000331
    • NPL1000334
    • NPL1000343
    • NPL1000344
    • NPL1000361
    • NPL1000363
    • NPL1000367
    • NPL1000370
    • NPL1000486
    • NPL1000501
Amount recalled
319 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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Where this came from

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

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:53 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.