Use caution Medical device recall · FDA · Published April 3, 2025

Medtronic Enhanced Verify Handset Recall: Communication Failure May Stop Therapy

Medtronic recalls Enhanced Verify Evaluation Handsets (CFN HH90130FA) due to potential communication failure with neurostimulators, which may cause therapy interruption and return of symptoms like urinary retention or incontinence.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1704-2025Medical device Medtronic ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmMedtronic Neuromodulation7000 Central Ave Ne · Minneapolis, MN 55432-3568

✎ GovInfoNow plain-language explainer

Medtronic is recalling Enhanced Verify Evaluation Handsets (CFN HH90130FA) because they may not communicate properly with neurostimulators. This could stop therapy delivery and cause symptoms like urinary retention or incontinence to return. Read more at govinfonow.com/recall/52499-medtronic-enhanced-verify-handset-recall-communication-failure-may-stop-therapy.

Source Summary by GovInfoNow · govinfonow.com/recall/52499-medtronic-enhanced-verify-handset-recall-communication-failure-may-stop-therapy · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1704-2025

Cite this page

“Medtronic Enhanced Verify Handset Recall: Communication Failure May Stop Therapy.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/52499-medtronic-enhanced-verify-handset-recall-communication-failure-may-stop-therapy. Based on FDA recall #Z-1704-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1704-2025%22&limit=1).

The FDA announced on April 3, 2025, that Medtronic Neuromodulation is recalling Enhanced Verify Evaluation Handsets (CFN HH90130FA) because they may not communicate with the neurostimulator. This failure can stop therapy delivery and cause patients to experience a return of underlying disease symptoms.

How to tell if you have it

Brand: Medtronic
Product: Enhanced Verify Evaluation Handset (CFN HH90130FA)
UDI-DI: 00763000930042
Serial Nos/Lots: NPN0076461 through NPN0077430 (specific codes listed in record)
Units affected: 534

The hazard

The evaluation handsets have a faster processing speed than prior handsets, which may prevent communication with the neurostimulator. An inability to connect causes the therapy to stop being delivered and displays a system error. Patients may experience a return of underlying disease symptoms such as overactive bladder, urinary retention, or fecal incontinence.

Context

GovInfoNow's records show Medtronic Neuromodulation has had 45 other recalls since August 9, 2017. Recent Medtronic Neuromodulation recalls include Pocket Adaptor Kits with Incorrect Use-By Dates (May 13, 2026) and SynchroMed Flex Infusion Software Issues (April 8, 2026). Other recent recalls of similar products include Philips Telemetry Monitor 5500 1.4 GHz Recall (June 5, 2026), Medline Medical Procedure Kits Recall (May 4, 2026), and Medtronic MiniMed 780G Insulin Pump Recall (May 27, 2026).

How to tell if you have this one

Check for the model CFN HH90130FA on the handset. The serial numbers listed in the recall include NPN0076461 through NPN0077418. These handsets were sold with specific neurostimulator systems.

Brand
Medtronic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Handset Model
Identify if your handset is model CFN HH90130FA by checking the label on the device.
Contact Medtronic
Reach out to Medtronic for guidance on whether your device is affected and next steps.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 27 states.

FDA distribution: “US Nationwide distribution including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, LA, MA, MD, MI, MN, MS, NC, NE, NJ, NM, NY, OH, OR, PA, TX, WA, WI.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Arizona, Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, New Mexico, New York, North Carolina, Ohio, Oregon, Pennsylvania, Texas, Washington, Wisconsin.

Recall timeline

FDA published this recall 34 days after the firm started it.

Apr 3, 2025Firm started the recall
Apr 30, 2025FDA classified it Class II
May 7, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/52499-medtronic-enhanced-verify-handset-recall-communication-failure-may-stop-therapy">Medtronic Enhanced Verify Handset Recall: Communication Failure May Stop Therapy (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1704-2025 (April 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1704-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.