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Terminated

Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604

FDA Recall Z-0934-2007 · Posted 2007-06-15

Recalling FirmMedtronic Neuromodulation
Recall StatusTerminated
Product CodeMHY
Date Initiated2007-04-16
Date Terminated2008-02-24
Product Quantity31 kits

Reason for Recall

Mislabeling: The inner package labeling incorrectly specified the model number of the lead as 3387-40. The outer package labeling is correct and the package actually contains the correct lead (3389S-40).

Firm Action

Medtronic field personnel visited affected customers and retrieved product from this lot, unless the product was needed for an imminent scheduled surgery. Telephone scripts and leave behind letters to each consignee were initiated in April 2007.

Root Cause

Other

Distribution Pattern

Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.

Official Source

View FDA Recall →

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

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