Z-0693-2008

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

Name: Z-0693-2008 Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc...
Creator: Medtronic Neuromodulation
Published: 2007-10-01
License: https://open.fda.gov/license/

Medtronic Neuromodulation / initiated 2007-10-01 / Terminated / root cause: packaging

FDA source

Medtronic Neuromodulation began a recall of Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic... on 2007-10-01. The reason FDA records is "Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0693-2008
Status: Terminated
Initiated: 2007-10-01
Posted: 2008-02-05
Terminated: 2012-05-03
Recalling firm: Medtronic Neuromodulation
Product: Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)
Product code: MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor
Reason for recall: Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.
Root cause tag: packaging
FDA root cause: Packaging change control
Action: A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.
Quantity in commerce: 1,427
Distribution: Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom
Product codes and lots: NFD100921H, NFD100922H, NFD100924H, NFD100925H, NFD100926H, NFD100928H, NFD100930H, NFD100931H, NFD100932H, NFD100939H, NFD100940H, NFD100941H, NFD100943H, NFD100944H, NFD100945H, NFD100946H, NFD100947H, NFD100948H, NFD100949H, NFD100950H, NFD100951H, NFD100952H, NFD100960H, NFD100961H, NFD100963H, NFD100964H, NFD100965H, NFD100966H, NFD100967H, NFD100968H, NFD100969H, NFD100970H, NFD100971H, NFD100974H, NFD100978H, NFD100980H, NFD100982H, NFD100983H, NFD100985H, NFD100986H, NFD100996H, NFD100997H, NFD100998H, NFD100999H, NFD101000H, NFD101002H, NFD101003H, NFD101005H, NFD101006H, NFD101007H, NFD101008H, NFD101009H, NFD101010H, NFD101011H, NFD101012H, NFD101013H, NFD101014H, NFD101015H, NFD101017H, NFD101018H, NFD101020H, NFD101021H, NFD101023H, NFD101024H, NFD101025H, NFD101026H, NFD101027H, NFD101028H, NFD101030H, NFD101031H, NFD101033H, NFD101035H, NFD101036H, NFD101037H, NFD101038H, NFD101040H, NFD101041H, NFD101042H, NFD101043H, NFD101044H, NFD101045H, 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NFD628353S, NFD628354S, NFD628355S, NFD628357S, NFD628359S, NFD628362S, NFD628364S, NFD628365S, NFD628366S, NFD628367S, NFD628370S, NFD628371S, NFD628377S, NFD628378S, NFD628379S, NFD628383S, NFD628385S, and NFD628386S

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)