Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563
FDA Recall Z-1080-06 · Posted 2006-06-07
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Recalling FirmGuidant Endovascular Solutions, Inc.
Recall StatusTerminated
Product CodeFGE
Date Initiated2006-03-22
Date Terminated2012-08-13
Product QuantityApproximately 38,203 units (all part #s) distributed US
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.
Firm Action
Identify 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.
Root Cause
Other
Distribution Pattern
Nationwide
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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