Reported May 7, 2025 · Ongoing

Enhanced Verify Evaluation Handset (CFN HH90130FA)

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?

  • Enhanced Verify Evaluation Handset (CFN HH90130FA)
Lot codes and dates
  • UDI-DI 00763000930042 Serial Nos/Lots

    534 of 534 codes

    • NPN0076461
    • NPN0076462
    • NPN0076465
    • NPN0076466
    • NPN0076467
    • NPN0076468
    • NPN0076469
    • NPN0076470
    • NPN0076471
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    • NPN0076499
    • NPN0076500
    • NPN0076501
    • NPN0076502
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    • NPN0076509
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Amount recalled
534

Where it was sold

Why it was recalled

Evaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An inability to connect may cause the therapy to stop being delivered and a system error will be displayed. Patient may experience return of underlying disease symptoms (e.g. overactive bladder, urinary retention, or fecal incontinence) based on their response to stimulation during the evaluation period.

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, 6:59 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.