CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report
Medtronic, Lead Kit for DBS Stimulation recalled
Medtronic Neuromodulation is recalling Medtronic, Lead Kit for DBS Stimulation, distributed in 11 states. The recall was initiated on 10 Jun 2016 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2602-2016
- FDA event ID
- 74545
- Recalling firm
- Medtronic Neuromodulation, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Jun 2016
- FDA classified
- 19 Aug 2016
- Reported
- 31 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 10 Jun 2016 | Recall initiated by company | |
| 19 Aug 2016 | Classified by FDA | +70 days |
| 31 Aug 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Where it was distributed
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
ArkansasCaliforniaFloridaIllinoisMarylandMissouriNebraskaNew YorkOhioTennesseeWisconsin
Questions about this recall
Is Medtronic, Lead Kit for DBS Stimulation recalled?
Yes. Medtronic Neuromodulation recalled Medtronic, Lead Kit for DBS Stimulation on 10 Jun 2016. The recall is Class II and its status is Terminated. Recall number Z-2602-2016.
Why was it recalled?
Medtronic has voluntarily decided to retrieve unused Model 3387S-40 and 3389S-40 DBS leads from three manufacturing lot numbers. During the manufacturing process of a DBS lead component, Medtronic identified the potential for lead insulation damage.
Which lots are affected?
lots: VA15GPJ, VA15K3N, VA15K7K
Where was it sold?
US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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