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.
FDA Recall Z-0642-2009 · Posted 2009-03-18
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Recalling FirmMedtronic Cardiovascular
Recall StatusTerminated
Product CodeFGE
Date Initiated2008-11-24
Date Terminated2009-03-27
Product Quantity23 units
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
Nationally in the states of NY, TX, CA, IA, AZ, PA, IN, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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