Medtronic COMPLETE SE Self Expanding Biliary Stent System, Model number SC760L, includes a pre-loaded self-expanding Nickel-Titanium (Nitinol) stent with 8 tantalum radiopaque markers, 4 on each end, and an over the wire retractable sheath delivery system.
This recall has been terminated (originally issued March 18, 2009).
- Company
- Medtronic Cardiovascular
- Recall Initiated
- November 24, 2008
- Posted
- March 18, 2009
- Terminated
- March 27, 2009
- Recall Number
- Z-0642-2009
- Quantity
- 23 units
- Firm Location
- Santa Rosa, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeled: Product may contain wrong instructions for use-- may contain International IFU instead of the correct US (for Biliary indication use only) IFU.
Distribution
Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.
Lot / Code Info
Lot #0000767722
Root Cause
Process control
Action Taken
Medtronic sent a notification entitled "URGENT - VOLUNTARY MEDICAL DEVICE RECALL" to consignees on 11/21/2008. All products are to be returned to the firm's distribution center. For further information, please contact Medtronic Cardiovascular by telephone at 707-566-0111.
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