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Terminated

Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).

FDA Recall Z-2602-2016 · Posted None

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeMHY
Date Initiated2016-06-10
Date Terminated2016-10-03
Product Quantity70

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.

Firm Action

Consignees were delivered in person by Medtronic Field Representatives a "Medical Device Removal" letter dated June 2016. The letter described the problem and the product involved in the recall. Advised consignees to return the unused product and to complete the Customer Confirmation Form. For questions contact Medtronic Technical Services at 800-707-09033 weekdays 7 am - 6 pm, or contact your Medtronic representative.

Root Cause

Process design

Distribution Pattern

US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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