Z-0290-2007

Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic...

Name: Z-0290-2007 Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic...
Creator: Medtronic Neurological
Published: 2006-07-19
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2006-07-19 / Terminated

FDA source

Medtronic Neurological began a recall of Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN... on 2006-07-19. The reason FDA records is "A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0290-2007
Status: Terminated
Initiated: 2006-07-19
Posted: 2006-12-19
Terminated: 2007-04-18
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: A subset of Kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. Sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
FDA root cause: Other
Action: Letter dated July 2006. Recommendations were made to Health Care Providers of the following: 1.Consider the potential for this anomaly if your patient present with a device in a POR state. 2. Consider informing your patients of this risk and advise them to seek attention immediately if they experience a return of pre-implant or more advanced symptoms. 3. Determine whether device replacement is warranted based upon consultation with your patient, review of the patient''s medical history and consideration of the relative risks of abrupt cessation of stimulation versus the risk of a device replacement surgical procedure. 4. Report any malfunction, removal and replacement to Medtronic and FDA suing the medical device reporting system. 5. Acknowledge this communication using the reply form enclosed.
Quantity in commerce: 6726 devices
Distribution: Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
Product codes and lots: serial numbers in the following ranges: ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K

Product code MHY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)