Guidant Cardiac Surgery
FDA adverse event reports naming Guidant Cardiac Surgery as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: GUIDANT CARDIAC SURGERY.
- Total reports
- 5,088
- Deaths
- 2
- Injuries
- 655
- Malfunctions
- 4,406
Reports per year
Source: FDA adverse event reports by year received, 2000–2009. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
- Clamp, VascularDXC3,463
- Laparoscope, General & Plastic SurgeryGCJ752
- Electrosurgical, Cutting & Coagulation & AccessoriesGEI751
- Stabilizer, HeartMWS71
- System, Ablation, Microwave And AccessoriesNEY22
- Instruments, Surgical, CardiovascularDWS16
- Product code KOGKOG6
- Gastroscope And Accessories, Flexible/RigidFDS4
- Lavage, JetFQH2
- Electrode, Pacing And Cardioversion, Temporary, EpicardialNHW1
Recent recalls
- 2010-12-13TerminatedPackaging
Heartstring II Proximal Seal / VASOVIEW 6 Endoscopic Vessel Harvesting System, Model Number: VH-2000, Product is manufactured and distributed by Maquet Corporation San Jose, CA
Sterility may be compromised by a loss of package integrity.
- 2008-12-23TerminatedPackaging process control
VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874.
- 2007-03-16TerminatedOther
Guidant Acrobat Vacuum Stabilizer, Model Number OM-9000.
Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
- 2007-03-16TerminatedOther
Guidant Acrobat Vacuum Stabilizer, Model number-OM-9100
Vacuum Tubing Failure- vacuum tubing fails before the labeled two year shelf life. This may result in partial or complete vacuum loss during surgery.
- 2005-08-24TerminatedOther
Aortic Cutter, single use device consisting of grip, cutter, aortic stops, needle, safety lock and actuation button.
Incomplete or no aortotomy may occur with use of the aortic cutter on unaltered tissue, or incomplete aortotomy may result when the cutter is used on altered tissue. Use of the cutter on altered tissue has caused the aortic plug to not be captured by the device
- 2004-07-20TerminatedNonconforming Material/Component
Guidant Brand VasoView 5 Harvesting Cannula System, Model Number: VH-1000
VasoView 5 scissors are stiff and/or the scissor toggle has the potential to break during use.
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