Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
FDA adverse event reports and recall history for temporary coronary saphenous vein bypass graft for embolic protection (product code NFA), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 2,032
- Deaths
- 38
- Injuries
- 777
- Malfunctions
- 1,189
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2006-07-28TerminatedOther
TriActiv ProGuard Embolic Protection System, Part number 61000-01. The product is shipped as a procedure kit. It is used with a standard 6F guide catheter using the standard femoral approach.
Alarm activiation-A priming issue involving the flow control unit due to a software problem has caused false postive Extraction Line Block (ELB) alarming. Use of this product may result in a health hazard resulting from early termination of the flush and extraction procedure after stenting
- 2006-07-12TerminatedOther
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using the standard femoral approach.
Volume control knob not able to go up to larger diameters
- 2006-07-12TerminatedOther
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit, ShieldWire (temporary occlusion balloon guidewire), and Balloon Inflation Syringe). The system is used with a standard 7F guide catheter using femoral approach.
volume control knob not able to go up to larger diameters
- 2006-07-12TerminatedOther
TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
volume control knob not able to go up to larger diameters
Monitor temporary coronary saphenous vein bypass graft for embolic protection automatically
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