Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
Reported: August 31, 2016 Initiated: June 10, 2016 #Z-2602-2016
Product Description
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
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.
Details
- Recalling Firm
- Medtronic Neuromodulation
- Units Affected
- 70
- Distribution
- US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).. Recalled by Medtronic Neuromodulation. Units affected: 70.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on August 31, 2016. Severity: Moderate. Recall number: Z-2602-2016.
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