Medtronic DBS Lead Kit for Deep Brain Stimulation, 3389S-40, Medtronic, Inc. Minneapolis, MN 55432-5604
FDA device recall Z-0934-2007 · posted 2007-06-15 · Terminated
Recall details
- Recalling firm
- Medtronic Neuromodulation
- 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).
- Action taken
- 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
- Status
- Terminated
- Product code
- MHY
- Quantity affected
- 31 kits
- Distribution
- Nationwide including states of CA, CO, IL, IN, MD, NC, OH, PA, and WV.
- Date initiated
- 2007-04-16
- Date posted
- 2007-06-15
- Date terminated
- 2008-02-24
- Location
- Minneapolis, MN
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