Z-1083-06

Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566

Name: Z-1083-06 Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566
Creator: Guidant Endovascular Solutions, Inc.
Published: 2006-03-22
License: https://open.fda.gov/license/

Abbott Vascular / initiated 2006-03-22 / Terminated / root cause: design

FDA source

Guidant Endovascular Solutions, Inc. began a recall of Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566 on 2006-03-22. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1083-06
Status: Terminated
Initiated: 2006-03-22
Posted: 2006-06-07
Terminated: 2012-08-13
Recalling firm: Abbott Vascular
Product: Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.
Product code: FGE Stents, Drains And Dilators For The Biliary Ducts
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.
Root cause tag: design
FDA root cause: Other
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.
Quantity in commerce: Approximately 38,203 units (all part #s) distributed US
Distribution: Nationwide
Product codes and lots: 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.

Product code FGE

K033393Class IIAbsolute .035 Self-Expanding Biliary Stent SystemGuidant Corp. / cleared 2003-11-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)