Guidant Endovascular Solutions
FDA adverse event reports naming Guidant Endovascular Solutions as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GUIDANT ENDOVASCULAR SOLUTIONS.
- Total reports
- 2,551
- Deaths
- 162
- Injuries
- 1,966
- Malfunctions
- 415
Reports per year
Source: FDA adverse event reports by year received, 2003–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- System, Endovascular Graft, Aortic Aneurysm TreatmentMIH1,551
- Stent, CarotidNIM478
- Temporary Coronary Saphenous Vein Bypass Graft For Embolic ProtectionNFA147
- Dilator, Vessel, For Percutaneous CatheterizationDRE113
- Stents, Drains And Dilators For The Biliary DuctsFGE77
- Stent, CoronaryMAF63
- Catheter, Angioplasty, Peripheral, TransluminalLIT48
- Temporary Carotid Catheter For Embolic CaptureNTE16
- Wire, Guide, CatheterDQX13
- Catheter, PercutaneousDQY11
Recent recalls
- 2006-06-07TerminatedOther
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part # FG1010563
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.
- 2006-06-07TerminatedOther
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010564.
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.
- 2006-06-07TerminatedOther
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010565.
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.
- 2006-06-07TerminatedOther
Guidant ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010566.
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.
- 2006-06-07TerminatedOther
ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter)- Base Part #FG1010567.
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.
- 2006-06-07TerminatedOther
ABSOLUTE .035 Biliary Self-Expanding Stent System, 135 cm Length (Catheter), Base Part #FG1010568.
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.
- 2005-09-24TerminatedOther
Guidant OTW OMNILINK .018 & .035 Biliary Stent Systems
This action is being taken as a preventative measure as a result of an increased rate of complaints associated with stents becoming loose or dislodged from the delivery catheter.
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