Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Cardiovascular · 21 CFR 870.1250
Recent MDR events
2,032 adverse event reports on file
- FilterWire EZ?Jul 29, 2026MalfunctionBoston Scientific Corporation2124215-2026-40559
- FILTERWIRE EZ?Jul 21, 2026InjuryBoston Scientific Corporation2124215-2026-39111
- FILTERWIRE EZJul 8, 2026MalfunctionBoston Scientific Corporation2124215-2026-36708
- FILTERWIRE EZ?Jul 7, 2026MalfunctionBoston Scientific Corporation2124215-2026-36344
- FILTERWIRE EZJul 2, 2026MalfunctionBoston Scientific Corporation2124215-2026-35654
- SPIDERFX 4MMJun 25, 2026MalfunctionMedtronic25619659
- FILTERWIRE EZ?Jun 23, 2026MalfunctionBoston Scientific Corporation2124215-2026-33304
- FILTERWIRE EZJun 16, 2026MalfunctionBoston Scientific Corporation2124215-2026-32171
- FILTERWIRE EZJun 16, 2026MalfunctionBoston Scientific Corporation2124215-2026-32162
- MEDTRONIC SPIDERFX 3MM FILTER DEVICE EMBOLJun 9, 2026InjuryMedtronic, Inc.MW5189099
Event type breakdown
Recalls
4 recall events for this product code
- Kensey Nash CorpTerminatedJul 28, 2006
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
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
Z-1305-06 · View FDA record ↗ - Kensey Nash CorpTerminatedJul 12, 2006
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 190 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit,
Volume control knob not able to go up to larger diameters
Z-1219-06 · View FDA record ↗ - Kensey Nash CorpTerminatedJul 12, 2006
TriActiv System Procedure Kit. Balloon Protected Flush Extraction System 340 cm (for embolism protection). The kit includes AutoStream Flow Control, Flush Kit,
volume control knob not able to go up to larger diameters
Z-1220-06 · View FDA record ↗ - Kensey Nash CorpTerminatedJul 12, 2006
TriActiv System Balloon Inflation Syringe. The syringe packs/boxes contain 5 'spare' syringes.
volume control knob not able to go up to larger diameters
Z-1221-06 · View FDA record ↗
Registered firms
7 firms currently registered for this product code
Isomedix Operations, Inc.
Minneapolis, MN, US
Boston Scientific Corporation
El Coyol Alajuela, CR
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Boston Scientific Corporation
La Aurora Heredia, CR
Boston Scientific Corporation
Saint Paul, MN, US
Medtronic, Inc.
Plymouth, MN, US
Synergy Health Ast, Srl
Alajuela, CR
510(k) clearances
22 clearances for this product code
- Medtronic, Inc.Aug 1, 2008
K073523 · INTERCEPTOR PLUS CORONARY FILTER SYSTEMS
- St Jude MedicalJan 31, 2008
K073563 · MODIFICATION TO PROXIS SYSTEM
- Ev3, Inc.Jan 19, 2007
K063785 · SPIDERFX EMBOLIC PROTECTION DEVICE
- Kensey Nash Corp.Oct 20, 2006
K062870 · TRIACTIV FX EMBOLIC PROTECTION SYSTEM, MODEL PN 60040-02; -03
- St Jude MedicalSep 13, 2006
K060651 · PROXIS SYSTEM, MODEL EPS101
- Velocimed, Inc.Sep 7, 2006
K052523 · PROXIS SYSTEM
- Ev3, Inc.Aug 11, 2006
K062201 · SPIDERX EMBOLIC PROTECTION DEVICE
- Boston Scientific CorpAug 11, 2006
K061332 · FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)