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U.S. Department of Health and Human Services

Class 2 Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent System

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 Class 2 Device Recall ABSOLUTE .035 Biliary SelfExpanding Stent Systemsee related information
Date Initiated by FirmMarch 22, 2006
Date PostedJune 07, 2006
Recall Status1 Terminated 3 on August 13, 2012
Recall NumberZ-1083-06
Recall Event ID 35099
510(K)NumberK033393 
Product Classification Biliary Self-Expanding Stent System - Product Code FGE
ProductGuidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.
Code Information All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010566; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
Recalling Firm/
Manufacturer		 Guidant Endovascular Solutions, Inc.
26531 Ynez Rd
Temecula CA 92591-4630
For Additional Information ContactDon Swanston
951-914-2774
Manufacturer Reason
for Recall		Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment of the stent, therefore patients in whom a stent has successfully been implanted are not affected by this action.
FDA Determined
Cause 2		Other
ActionIdentify all customers who have been shipped affected product 2) Deliver Physician Medical Device Recall Notice and Reconciliation Form via Federal Express 3) Guidant field representatives contact hospitals by phone and in person to reinforce letter and recall plan4) Reconcile receipt notifications and physical product returns to expected returns.
Quantity in CommerceApproximately 38,203 units (all part #s) distributed US
DistributionNationwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FGE
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