Z-0861-06

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

Name: Z-0861-06 Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc...
Creator: Medtronic Neurological
Published: 2006-04-04
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2006-04-04 / Terminated

FDA source

Medtronic Neurological began a recall of Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604... on 2006-04-04. The reason FDA records is "A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0861-06
Status: Terminated
Initiated: 2006-04-04
Posted: 2006-05-27
Terminated: 2006-12-26
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case.
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: A specific subset of model 7428 Kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. This failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
FDA root cause: Other
Action: An Urgent Device Recall Important Patient Management Information letter was sent to implanting and following physicians of patients who have received the device. The letter describes the issue and provides recommendations.
Quantity in commerce: 24
Distribution: USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
Product codes and lots: NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S, NFD622542S, NFD622564S, NFD622629S, NFD622664S

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)