FDA Recall for a DBS Neurostimulator: How to Check Your Device

If you have an implanted deep brain stimulation (DBS) device, an FDA recall notice can feel scary—but you don’t need to panic. The practical next step is to verify your DBS device identifiers against the specific FDA record, and contact your DBS care team if your device is possibly included.

FDA’s recall record for the Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation (model 7428) notes a potential issue that may lead to sudden cessation of therapy in a subset of devices. FDA also warns that sudden therapy cessation can result in the immediate return or worsening of underlying symptoms. (FDA notes the record was last updated 07/16/2026.)

What an FDA medical device recall record is (and why it matters)

An FDA medical device recall record is a structured entry describing a safety issue and the actions the firm and FDA are coordinating. FDA also explains that a recall record is created when a firm initiates a correction or removal action, can be updated as FDA classifies the action, and is updated again when the recall is terminated.

That’s why these entries are often model- and serial-number-specific—not every device made by a company is automatically included in every recall.

DBS basics: what the neurostimulator does

DBS uses a neurostimulator (a pacemaker-like device) and leads/electrodes to deliver electrical signals to targeted areas of the brain. MedlinePlus explains the DBS system includes leads placed in the brain and a neurostimulator that generates the electrical current.

Because stimulation is part of therapy, when stimulation stops unexpectedly, symptoms that were previously improved may return or worsen.

The International Parkinson and Movement Disorder Society also emphasizes that DBS improves symptoms for many people but doesn’t cure Parkinson’s disease or stop its progression—so changes in stimulation delivery can change how symptoms look.

Step-by-step: check whether your Medtronic Kinetra (model 7428) is potentially included

This FDA record targets a subset of devices. The key identifiers FDA lists are the model and serial-number ranges.

Find your device identifiers (from your implant paperwork or your DBS clinic records). You’re looking for:
- Model number
- Serial number
Confirm the model. FDA’s recall record is for Medtronic Kinetra model 7428.
Compare your serial number to FDA’s ranges listed for this record:
- NFD100006 – NFD100325H
- NFD620017S – NFD625737S
- NFD200201K – NFD201303K
If you match a listed range, contact your DBS team promptly for next steps. Don’t assume the recall means something is already wrong with your device—your clinician can guide what should happen for your specific system.

What the FDA record describes in practical terms

FDA’s recall entry describes a potential failure of wire connections between the electronic hybrid circuit and battery in a subset of Kinetra implantable neurostimulators. FDA notes this may lead to sudden cessation of therapy.

FDA also explains that sudden therapy cessation can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.

What FDA says clinicians/patients should do

FDA’s action letter (reflected in the recall entry) includes recommendations such as:

Considering the potential anomaly if a patient presents with the device in a specified “POR state”.
Informing patients of the risk and advising attention if symptoms suggest return of pre-implant or more advanced symptoms.
Deciding whether device replacement is warranted through consultation and shared decision-making, weighing the risks of abrupt stimulation cessation against the risks of a replacement surgery.
Reporting malfunctions, removals, and replacements through the appropriate medical device reporting process.

When to call your neurologist or neurosurgeon

Call your DBS treating team promptly if:

Your model and serial number match this FDA record’s listed ranges, and/or
You notice a meaningful return or worsening of symptoms that were previously improved with stimulation.

If you’re not sure how to interpret your device identifiers or what your current therapy status means, ask your clinic—DBS systems are individualized.

When to escalate to urgent or emergency care

Some serious neurologic problems can look sudden. If you have seizure activity or loss of consciousness, follow CDC seizure first-aid guidance and seek emergency care.

Call 911 if a seizure lasts longer than 5 minutes, if there’s another seizure soon after the first, if there’s trouble breathing or waking up after a seizure, if the person is injured, or if the seizure happens in water. CDC also advises calling 911 if the person has never had a seizure before, has diabetes and loses consciousness, or is pregnant.

If symptoms are sudden and severe—even if they don’t look exactly like a seizure—get emergency evaluation, especially with loss of consciousness or trouble breathing.

Bottom line: act today—without panic

Check your device model and serial number against the FDA record for Medtronic Kinetra model 7428.
If you’re potentially included, contact your DBS care team promptly for individualized next steps.
If you have severe sudden neurologic symptoms (including seizure activity, loss of consciousness, or trouble breathing), call 911 and follow CDC first-aid guidance.

Key sources

Editorial note: Weence articles are researched from cited public-health, medical, regulatory, journal, and reputable news sources and may be drafted with AI assistance. They are checked for source support, clarity, and safety guardrails before publication.

This article is for general informational purposes only and is not medical advice. Research findings can be early or incomplete, and health guidance can change. Always talk with a qualified healthcare professional about personal symptoms, diagnosis, medications, vaccines, screenings, or treatment decisions. If you think you may have a medical emergency, call emergency services right away.