Edwards Lifesciences, Llc
Draper, UT
This page shows every FDA and USDA recall linked to Edwards Lifesciences, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
31
Total Recalls
2010
First Recall
2019
Most Recent
Edward Lifesciences, Edwards Commander Delivery System:
Model Number UDI Number
9600LDS20A (US) 00690103193930...
Jan 22, 2019
· Device
Terminated
Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model...
Mar 30, 2018
· Device
Terminated
Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A
P...
Jan 10, 2018
· Device
Terminated
Thin-Flex Venous Cannula, Model Number:TF292902A
Dec 9, 2015
· Device
Terminated
ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement...
Sep 18, 2015
· Device
Terminated
Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (...
Jun 11, 2015
· Device
Terminated
Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer E...
Apr 2, 2015
· Device
Terminated
Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model...
Nov 14, 2014
· Device
Terminated
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French,...
Apr 16, 2014
· Device
Terminated
Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae with Duraflo Coating, arterial cannula sizes 16...
Apr 16, 2014
· Device
Terminated
Crimper Model 9100CR26
The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart V...
Feb 3, 2014
· Device
Terminated
Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330....
Dec 21, 2013
· Device
Terminated
Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For...
Nov 1, 2013
· Device
Terminated
Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use...
Nov 1, 2013
· Device
Terminated
Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD,...
Oct 31, 2013
· Device
Terminated
Edwards EndoReturn Arterial Cannula, model ER21B and ER23B
Product Usage:
The ThruPort EndoReturn arterial ca...
Aug 14, 2013
· Device
Terminated
Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512,...
Aug 14, 2013
· Device
Terminated
Edwards Lifesciences Suction Wand, models S099 and S0998B
Suction wands are intended for hand held use and pe...
Jul 17, 2013
· Device
Terminated
QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The produ...
Jun 13, 2013
· Device
Terminated
Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9.
Product Usage: The cathe...
May 14, 2013
· Device
Terminated
Edwards Lifesciences Crimpers, Model 9100CR23.
The Crimpers are used to crimp the transcatheter heart valve...
Apr 17, 2013
· Device
Terminated
Edwards Lifesciences Crimpers, Model 9100CR26.
The Crimpers are used to crimp the transcatheter heart valve...
Apr 17, 2013
· Device
Terminated
Edwards Lifesciences Duraflo coated Femoral Cannula.
Product Usage:
The cannulae are intended for use in s...
Apr 14, 2013
· Device
Terminated
Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081.
Product Usage: These suc...
Jul 9, 2012
· Device
Terminated
Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Syst...
Jul 11, 2011
· Device
Terminated
Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine,...
Jul 11, 2011
· Device
Terminated
Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards...
May 13, 2011
· Device
Terminated
EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesc...
Jan 28, 2011
· Device
Terminated
Steerable Coronary Sinus Catheter Kit, REF SCS01, 9 Fr x 20.4", Contains Phthalates, Sterile EO, Edwards Lifes...
Jan 28, 2011
· Device
Terminated
Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC...
Dec 7, 2010
· Device
Terminated
Edwards Protection Cannulae - Monitoring and Infusion Set, Model MIS004, Sterile EO, Edwards Lifesciences LLC,...
Dec 7, 2010
· Device
Terminated