Stent, Superficial Femoral Artery
Unknown
Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
Recent MDR events
10,573 adverse event reports on file
- PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONGJul 31, 2026MalfunctionCovidien2183870-2026-00352
- GORE® VIABAHN® FORTEGRA Venous StentJul 31, 2026MalfunctionW. L. Gore & Associates, Inc.3007284313-2026-04970
- GORE® VIABAHN® FORTEGRA Venous StentJul 31, 2026MalfunctionW. L. Gore & Associates, Inc.3007284313-2026-04974
- EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARDJul 30, 2026InjuryCovidien2183870-2026-00348
- GORE® VIABAHN® Endoprosthesis with HEPARIN Bioactive SurfaceJul 29, 2026MalfunctionW. L. Gore & Associates, Inc.2017233-2026-07833
- Pulsar-18 T3 5/60/90Jul 29, 2026MalfunctionBiotronik Ag8043892-2026-07142
- LifeStent 5F Vascular StentJul 28, 2026MalfunctionAngiomed Gmbh & Co. Medizintechnik Kg9681442-2026-00164
- SUPERAJul 28, 2026MalfunctionAbbott Vascular Inc.2024168-2026-02965
- Supera¿Jul 28, 2026InjuryAbbott Vascular Inc.2024168-2026-02980
- Innova? VascularJul 28, 2026MalfunctionBoston Scientific Corporation2124215-2026-40423
Event type breakdown
Recalls
86 recall events for this product code
- Medtronic Inc.CompletedJan 2, 2024
Protege GPS Self-Expanding Peripheral Stent System, product number SERB65-09-60-80, Sterile.
Seal defects could compromise the ability of the product packaging to maintain sterility.
Z-0623-2024 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedFeb 22, 2018
Innova Self-Expanding Stent System, 200 mm. Labeled with Material Number and description as follows:
Stent possibly unable to be fully released from the delivery system.
Z-0685-2018 · View FDA record ↗ - Boston Scientific CorporationOpen, ClassifiedFeb 22, 2018
Innova Self-Expanding Stent System, 180mm. Labeled with Material Number and description as follows:
Stent possibly unable to be fully released from the delivery system.
Z-0686-2018 · View FDA record ↗ - Bard Peripheral Vascular IncTerminatedOct 10, 2013
Bard LifeStent Solo Vascular Stent, Item Numbers: EX062001CL, EX072001CL, EX062003CL, EX072003CL.
Bard Peripheral Vascular is recalling specific lots of Bard Lifestent Solo Vascular Stent because they have determined a higher incidence rate of partial stent deployment associated with their use.
Z-0007-2014 · View FDA record ↗ - Cordis CorporationTerminatedJun 6, 2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Z-1508-2013 · View FDA record ↗ - Cordis CorporationTerminatedJun 6, 2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Z-1510-2013 · View FDA record ↗ - Cordis CorporationTerminatedJun 6, 2013
FLEXSTENT Femoropopliteal Self-Expanding Stent System.
Holes and/or tears can be introduced in the FLEXSTENT inner pouch under some conditions, and to a lesser degree, in the outer pouch.
Z-1511-2013 · View FDA record ↗ - Boston Scientific CorporationTerminatedJun 16, 2011
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05107. 5mm x 100 mm x 75 cm (stent diameter x stent length x delivery sys
Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d
Z-2469-2011 · View FDA record ↗ - Boston Scientific CorporationTerminatedJun 16, 2011
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05127. 5 mm x 120 mm x 75 cm (stent diameter x stent length x delivery sy
Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d
Z-2470-2011 · View FDA record ↗ - Boston Scientific CorporationTerminatedJun 16, 2011
Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39180-05157. 5 mm x 150 mm x 75 cm (stent diameter x stent length x delivery sy
Boston Scientific Corporation is conducting a recall of the Innova Self-Expanding Stent System because they have received 6 complaints involving no deployment/partial deployment of the Innova Stent. Potential health hazard events resulting from this type of failure include increased procedure time, vessel wall injury, and/or emergency surgery to remove the partially deployed stent. This recall d
Z-2471-2011 · View FDA record ↗
Registered firms
48 firms currently registered for this product code
Veryan Medical Limited
Galway, IE
Cordis Us Corp.
Miami Lakes, FL, US
Boston Scientific Corporation
Coventry, RI, US
Synergy Health Ast, Srl
Alajuela, CR
Sterigenics U.s., Llc
Salt Lake City, UT, US
Abbott Vascular Netherlands
Heerlen Limburg, NL
Ashitaka Factory Of Terumo Corp.
FUJINOMIYA Shizuoka, JP
Bard European Distribution Center Nv
Olen Antwerpen, BE
Abbott Vascular
SANTA CLARA, CA, US
Medtronic, Inc.
Plymouth, MN, US
Medistri Sa
Domdidier Fribourg, CH
Boston Scientific Corporation
Maple Grove, MN, US
Terumo Corp.
SHIBUYA-KU, TOKYO, JP
Cortronik Gmbh
Rostock-Warnemuende Mecklenburg-Western Pomerania, DE
Sterigenics Belgium Petit Rechain S.a.
Verviers Liege, BE
Boston Scientific Corporation
Saint Paul, MN, US
Sterigenics Us Llc
Los Angeles, CA, US
Cardinal Health Mexico 244 S De Rl De Cv
Ciudad Juarez Chihuahua, MX
Synergy Health Ireland Ltd
Tullamore Offaly, IE
Sterigenics Germany Gmbh
Wiesbaden Hesse, DE
Synergy Health Sterilisation Uk Ltd
Thorne Doncaster, GB
Angiomed Gmbh & Co. Medizintechnik Kg
KARLSRUHE Baden-Wurttemberg, DE
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.
PMA approvals
12 premarket approvals for this product code
- Veryan Medical, Ltd.Oct 4, 2018
P180003 · BioMimics 3D Vascular Stent System
- Biotronik AGMar 23, 2017
P160025 · ASTRON PULSAR STENT SYSTEM, PULSAR-18 STENT SYSTEM
- W. L. Gore & Associates, Inc.Jul 27, 2016
P160004 · GORE TIGRIS VASCULAR STENT
- Boston Scientific CorporationJul 21, 2015
P140028 · INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM
- Terumo Medical CorporationMay 22, 2015
P140002 · MISAGO PERIPHERAL SELF-EXPANDING STENT SYSTEM
- Abbott Vascular (Idef Technologies Inc)Mar 28, 2014
P120020 · SUPERA PERIPHERAL STENT SYSTEM
- Medtronic VascularSep 19, 2013
P110040 · MEDTRONIC VASCULAR COMPLETE SE VASCULAR STENT SYSTEM
- Cordis US CorporationNov 7, 2012
P120002 · SMA RT CONTROL AND SMART VASCULAR STENT SYSTEMS