FDA Medical Device Recalls (openFDA)
Guidant Endovascular Solutions, Inc.: Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564.
- Recall number
- Z-1081-06
- Recalling firm
- Guidant Endovascular Solutions, Inc.
- Product
- Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564.
- Status
- Terminated
- Initiated
- 2006-03-22
- Posted
- 2006-06-07
- Terminated
- 2012-08-13
- Reason
- 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
- 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
- Approximately 38,203 units (all part #s) distributed US
- Distribution
- Nationwide
- Lot, serial or model codes
- All part numbers and all lot numbers of the 135 cm length delivery catheter are affected: 1) Base Part # FG1010564; Suffix (Stent Length, mm) = -20, -30, -40, -60, -80, -100.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FGE
- Firm FEI
- 2024168
- Firm city
- Temecula
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28