Guidant Endovascular Solutions, Inc. Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563
Brand
Guidant Endovascular Solutions, Inc.
Lot Codes / Batch Numbers
Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
Products Sold
All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010563; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
Guidant Endovascular Solutions, Inc. is recalling Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG due to Design : increasing number of customer complaints with a trend of stent deployment difficulties. The difficulties are reported during acute deployment. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026