Data / Medical devices / United States / Edwards Lifesciences LLC
Edwards Lifesciences LLC: FDA-registered device maker in Irvine, CA, United States, 24 510(k) clearances and 10 PMA approvals
Edwards Lifesciences LLC is registered with the FDA (registration 2015691) in Irvine, CA, United States. It lists 25 device types. The FDA files 24 510(k) clearances and 10 PMA approvals under its listings, the newest dated October 1, 2026. 42 recall events name it as the recalling firm (6 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2015691
- Address
- One Edwards Way, Irvine, CA, United States, 92614
- Owner or operator
- Edwards Lifesciences LLC (9040666)
- Roles
- Manufacturer, Specification developer
- First device listed
- April 4, 1997
- Registered through
- 2027
- Brand names listed
- AUTUS Size-Adjustable Valve, Ascendra + Introducer Sheath Set, Ascendra Balloon Aortic Valvuloplasty Catheter, Ascendra+ Delivery System, Ascendra+ System, CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING, CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING, CARPENTIER-McCARTHY-ADAMS IMR ETLOGIX MITRAL ANNULOPLASTY RING and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 26, 2026 | K254232 | ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150) | PZX | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| April 17, 2026 | K254279 | Edwards eSheath+ introducer set | DYB | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| September 23, 2025 | K251982 | Edwards MC3 Tricuspid annuloplasty ring (4900) | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| September 17, 2025 | K251688 | Carpentier-Edwards Physio Annuloplasty Ring (4450) | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 29, 2025 | K252364 | Edwards eSheath Optima introducer set | DYB | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| March 27, 2025 | K244046 | Edwards eSheath Optima introducer set | DYB | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| August 28, 2024 | K240078 | Fogarty Thru-Lumen Embolectomy Catheter | DXE | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| August 22, 2022 | K221528 | Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter | DXF | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| March 9, 2020 | K200258 | Edwards eSheath Introducer Set | DYB | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| December 16, 2019 | K192762 | Physio Flex Annuloplasty Ring | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 7, 2016 | K153069 | Edwards Balloon Catheter | OMZ | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| October 29, 2014 | K142199 | Ascendra Balloon Aortic Valvaloplasty Catheter | OZT | Substantially Equivalent | Edwards Lifesciences | accessdata.fda.gov |
| July 3, 2014 | K140241 | EDWARDS TRANSFEMORAL BALLOON CATHETER | OZT | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 24, 2011 | K103520 | CARPENTIER-EDWARDS PHYSIO TRICUSPID ANNULOPLASTY RING | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| July 1, 2010 | K093877 | RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26 | DYB | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 15, 2009 | K083623 | CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| January 23, 2009 | K083470 | CARPENTIER- EDWARDS PHYSIO II ANNULOPLASTY, MODEL 5200 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| October 23, 2008 | K082139 | EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 | DXZ | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| April 17, 2002 | K020864 | EDWARDS MC TRICUSPID ANNULOPLASTY SYSTEM, MODEL 4900 | KRH | Substantially Equivalent | Edwards Lifesciences, LLC | accessdata.fda.gov |
| June 22, 1993 | K926138 | CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING | KRH | Unknown | Baxter Healthcare Corp | accessdata.fda.gov |
| January 6, 1993 | K923367 | COSGROVE EDWARDS ANNULOPLASTY SYSTEM, MODEL 4600 | KRH | Unknown | Baxter Healthcare Corp | accessdata.fda.gov |
| September 9, 1991 | K912554 | ANNULOPLASTY RINGS, MODEL 4400 MIRTAL AND 4500 TRI | KRH | Substantially Equivalent | Baxter Healthcare Corp | accessdata.fda.gov |
| May 16, 1991 | K910221 | RMI VASCULAR TOURNIQUET KIT | DXC | Substantially Equivalent | Research Medical, Inc. | accessdata.fda.gov |
| November 1, 1984 | K833763 | PERICARDIAL PATCH | DXZ | Substantially Equivalent | American Edwards Laboratories | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| October 1, 2026 | P260007 | Autus Size-Adjustable Valve | SJL | 0 | October 1, 2026 | accessdata.fda.gov |
| December 22, 2025 | P250019 | SAPIEN M3 Transcatheter Mitral Valve Replacement System | NPU | 5 | July 29, 2026 | accessdata.fda.gov |
| February 1, 2024 | P230013 | Edwards EVOQUE Tricuspid Valve Replacement System | NPW | 32 | October 21, 2026 | accessdata.fda.gov |
| September 14, 2022 | P220003 | PASCAL Precision Transcatheter Valve Repair System | NKM | 33 | October 22, 2026 | accessdata.fda.gov |
| August 31, 2020 | P200015 | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System | NPV | 80 | September 23, 2026 | accessdata.fda.gov |
| June 29, 2017 | P150048 | EDWARDS PERICARDIAL AORTIC BIOPROSTHESIS (MODEL 11000A) and EDWARDS INSPIRIS RESILIA AORTIC VALVE (MODEL 11500) | LWR | 97 | October 22, 2026 | accessdata.fda.gov |
| August 12, 2016 | P150036 | EDWARDS INTUITY ELITE VALVE SYSTEM | LWR | 77 | July 29, 2026 | accessdata.fda.gov |
| June 17, 2015 | P140031 | SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES | NPT | 202 | October 22, 2026 | accessdata.fda.gov |
| June 16, 2014 | P130009 | EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES | NPT | 101 | March 19, 2021 | accessdata.fda.gov |
| September 26, 1991 | P860057 | EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES | DYE | 210 | July 29, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 27, 2026 | 98633 | Class II | Ongoing | Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO | Labeling update to provide warning if functionality of the valve replacement delivery system is compromised. | accessdata.fda.gov |
| May 14, 2025 | 96943 | Class I | Ongoing | Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae prov | due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. | accessdata.fda.gov |
| October 4, 2023 | 93279 | Class II | Ongoing | Acumen IQ Sensor, REFs: AIQS6, AIQS65, AIQS6R, AIQS6R5, AIQS8, AIQS85, AIQS8R5, Rx only, Sterile EO. For use in intravascular pressure monitoring. | Their is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. | accessdata.fda.gov |
| September 7, 2023 | 93172 | Class II | Ongoing | Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35 | Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds). | accessdata.fda.gov |
| July 27, 2023 | 92804 | Class II | Ongoing | PASCAL Precision Transcatheter Valve Repair System, Models: 20000ISM and 20000IS | Due to a manufacturing issue, when using valve repair systems, intended to repair insufficient mitral and/or tricuspid valves, users experienced resistance when attempting to release the implant from the delivery system by rotating the release knob. Additional torque required to initiate rotation of the release wire from the implant, could cause implant rota | accessdata.fda.gov |
| February 14, 2023 | 91868 | Class II | Ongoing | Edward Lifesciences, REF 777F8, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 8F (2.7mm), Usable Length 110 cm, Recommended Guidewire size 0.018 (0.46mm), Minimum Introducer size 9F (3 | There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message. | accessdata.fda.gov |
| October 6, 2022 | 90905 | Class II | Ongoing | Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 120804FP 120805FP 120806FP 120807FP Fogarty Arterial Embolectomy Catheter with Stylet Model Number: 120403FSP 120803FSP | Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. | accessdata.fda.gov |
| March 1, 2022 | 89647 | Class II | Ongoing | FORE-SIGHT ELITE Absolute Tissue Oximeter, REF: 01-06-3000, Contents: Monitor 1 EA., Accessory Kit 1 EA. | The StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue Oximeter Monitor with the Fore-Sight Elite large sensor in certain somatic locations (arms and legs). While the StO2 absolute values are impacted, the directional trend remains accurate, but may have a larger magnitude | accessdata.fda.gov |
| July 9, 2021 | 88270 | Class II | Terminated | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01)00690103197563 | There is a potential for internal leaks within catheters. | accessdata.fda.gov |
| May 26, 2021 | 87993 | Class II | Terminated | Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit, REF: PXVJ356, Pressure Monitoring Set, RX Only, CE, Sterile EO, Sterilized using ethylene Oxide, UDI: (01) 57460691954507 | There is a potential that the pressure tubing may detach from the blood sampling system | accessdata.fda.gov |
| March 27, 2020 | 85483 | Class II | Terminated | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 | Sterile catheter kit packaging compromised. | accessdata.fda.gov |
| November 27, 2019 | 84381 | Class II | Terminated | QuickDraw Venous Cannula, REF: QD22, UDI: 00690103182699; and REF: QD25, UDI: 00690103182705 | If the venous cannula is used in an unintended manner (longer than 6 hours; particularly during extracorporeal membrane oxygenation [ECMO]) there is a risk that separation of the cannula from its connector can occur; which can result in significant blood loss. | accessdata.fda.gov |
| October 22, 2019 | 84065 | Class II | Terminated | EZ Glide Aortic Cannula, 24 Fr. (8.0mm) x 37.6 cm (14.8") 3/8" (9.5 mm) vented connector, RX Only, Sterile EC, Made in Mexico, UDI: 00690103172119 for the following REF #s (UDI): EZC21A (00690103174182), EZC21TA (0069010 | Their is a possibility that the cannula may separate from its connector, potentially causing a breach of circuit during cardiopulmonary bypass which could result in significant blood loss. | accessdata.fda.gov |
| October 7, 2019 | 85409 | Class II | Terminated | Oxymetry Cable, Rxonly. REF/UDI: HEMOXSC100/(01)00690103196986 - Product Usage: The HemoSphere oximetry cable is a multi-use device that connects with a compatible Edwards monitor on one end and any approved Edwards oxim | Intermittent communication due to inconsistent crimping of connectors onto cables. | accessdata.fda.gov |
| July 9, 2019 | 83293 | Class I | Terminated | Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239 | The action has been initiated to address reports of burst balloons which have resulted in significant difficulty retrieving the device into the sheath and withdrawing the system from the patient during procedures | accessdata.fda.gov |
| May 14, 2019 | 82870 | Class I | Terminated | IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing cardiopulmonary bypas | Possibility of balloon rupture in intra-aortic occlusion devices. If the balloon bursts during cardiopulmonary bypass, the heart can fill and warm, the operative site may be obscured, and the device will need to be exchanged or operative strategy would need to change, including placement of an external cross-clamp, conversion to an open procedure, or perform | accessdata.fda.gov |
| March 28, 2019 | 82455 | Class I | Terminated | Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial openings. In most pedi | Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment. | accessdata.fda.gov |
| March 21, 2019 | 82456 | Class I | Terminated | EV1000 Clinical Platform, Models: EV1000A, EV1000NI, EV1000CS Product Usage: EV1000A Monitor is used to optimize fluid management through the use of minimally invasive monitoring with the FloTrac sensor (or the Volume Vi | Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets. | accessdata.fda.gov |
| January 16, 2019 | 81928 | Class II | Ongoing | Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in orde | Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device. | accessdata.fda.gov |
| December 21, 2018 | 81878 | Class I | Terminated | Edwards Lifesciences Swan Ganz Thermodilution Catheter, REF131F 7J Product Usage: The Swan-Ganz Thermodilution Catheter provides a diagnostic tool for physicians to rapidly determine hemodynamic pressures and cardiac out | These Swan Ganz catheters have incorrect lumen assembly, which causes reversal of the lumens. If the lumens are reversed the clinician may note reverse PA and CVP pressure values and waveforms. | accessdata.fda.gov |
| June 11, 2018 | 80394 | Class II | Terminated | Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Model: 9600TFX, Size: 26 mm | SAPIEN 3 THV was packaged with the incorrect valve size with respect to the label. | accessdata.fda.gov |
| October 2, 2017 | 78442 | Class II | Terminated | Hemosphere System with the following three components: HEM1 Advanced Monitor, HEMSGM10 (Swan-Ganz Module), and HEMOXSC100 (Oximetry Smart Cable). Product Usage: The HemoSphere Advanced Monitor (HEM1) is intended to be us | Pre-procedural issues related to software defects | accessdata.fda.gov |
| July 6, 2017 | 77802 | Class II | Terminated | Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product Usage: The Fogarty adherent clot catheters are designed to effectively remove clot material in the peripheral vasculature. The catheters are indicat | The diameter of the Fogarty Catheter balloon, measures 6mm instead of 10mm. | accessdata.fda.gov |
| November 13, 2015 | 72690 | Class II | Terminated | Intravascular (IV) Administration Sets, Model No. 54IV12, 54IV22, 54IV32, MK2450, 54IV42, MK132, MK2156, MK2270, MK2292, MK2300, MK2374, MK2394, MK2508, MK2227 | Edward Lifesciences is recalling Intravascular (IV) Administration Sets due to the requirement of an additional FDA submission to support commercialization (clearance) of the devices. | accessdata.fda.gov |
| July 31, 2015 | 71971 | Class II | Terminated | Edwards Pressure Monitoring Kit with TruWave disposable pressure transducer. A sterile, single-use kit that monitors pressures when attached to pressure monitoring catheters. For use on patients requiring intravascular, | Flow restriction issues in a trifurcated IV set included in the pressure transducer kits. A restriction of the flow of IV fluid would result in either an inability to prime the system before use or difficulty in flushing the line after a blood draw. | accessdata.fda.gov |
| May 18, 2015 | 71246 | Class II | Terminated | ClearSight, Model No. EVHRS Heart Reference Sensor. The EV1000 Clinical Platform Nl and ClearSight finger cuffs noninvasively measures blood pressure and associated hemodynamic parameters. | Edward Lifesciences is recalling the ClearSight System because the finger component of the Heart Reference Sensor may be damaged. | accessdata.fda.gov |
| May 5, 2015 | 71169 | Class II | Terminated | Swan-Ganz CCO/Sv02/CEDV/VIP Thermodilution Catheters model number 744HF75. Flow-directed pulmonary artery catheters for monitoring cardiac output, mixed venous oxygen saturation, and end diastolic volume when used with t | The product failed to meet the internal established statistical test requirement for heparin activity. | accessdata.fda.gov |
| July 31, 2013 | 65984 | Class II | Terminated | "***Flo Trac Sensor Model MHD85***" Sterile, single use kit that monitors pressures when attached to pressure monitoring catheters. | The Edwards Lifesciences FloTrac Sensor is being recalled due to a manufacturing non-conformance related to incorrect packaging configuration where the IFU was placed on top of the Tyvek instead of being placed at the bottom of the box. There is no evidence available at this time that could validate the sterility of this incorrect packaging configuration. | accessdata.fda.gov |
| January 30, 2013 | 64229 | Class II | Terminated | Pressure Monitoring sets with VAMP Plus closed blood sampling system model # T001691A, PXVP0566, PXVP2260, PXVP0826, PXVP0827, PXVP2284AT3, PXVP23X3AT3, T398807D, T100605B, T001762A, T391T00A, VP2. Blood sampling system | The device is being recalled because the firm has received multiple complaints related to incorrect assembly that may result in dilution of blood samples. | accessdata.fda.gov |
| May 11, 2012 | 62278 | Class II | Terminated | Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. | The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter. | accessdata.fda.gov |
| June 25, 2010 | 56148 | Not yet classified | Terminated | Edwards' MHANM8 Pressure Slave Cable, Part Number:693657001 The Edwards Lifesciences Analog Slave Cable is used to transfer monitoring output from patient monitors to the analog input ports of the Vigileo Monitor series | The recall was initiated because the Edwards' MHANM8 Pressure Slave Cable was wired incorrectly, thus will not work as stated. | accessdata.fda.gov |
| June 22, 2009 | 52834 | Not yet classified | Terminated | Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion. | Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube. | accessdata.fda.gov |
| May 11, 2009 | 52629 | Not yet classified | Terminated | Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. | Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use. | accessdata.fda.gov |
| March 16, 2009 | 53554 | Not yet classified | Terminated | Edwards Lifesciences Aquarius System Model GEF09800. | There have been reports of clinically significant fluid imbalance when a certain level of fluid imbalance is detected the Aquarius will trigger an alarm, however, users are able to override this alarm and continue therapy. It is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this may result in serious injur | accessdata.fda.gov |
| February 9, 2009 | 51492 | Not yet classified | Terminated | Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right he | Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode". | accessdata.fda.gov |
| September 12, 2008 | 52807 | Not yet classified | Terminated | Vigilance II Monitor Model: VIG2/VIG2E Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73. Product Usage: The Vigilance II CCO/SvO2/CEDV Monitor is indicated for use in patients requi | Edwards Lifesciences has made the decision to initiate a field corrective action for the Edwards Vigilance II Model: Software: versions 00.51, 00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, 00.71, 00.73 due to the potential of inaccurate Injectate Cardiac Output (ICO) measurements. | accessdata.fda.gov |
| June 23, 2008 | 49003 | Not yet classified | Terminated | Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system. | Potential for tubing fracture near the tip of the catheter. | accessdata.fda.gov |
| December 5, 2007 | 46679 | Not yet classified | Terminated | Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060603CD; Edwards Lifesciences LLC, Irvine, CA 92614. | Incorrect Expiration Date: Products were labeled with an incorrect shelf-life expiration date. Therefore, the sterility of the device may be compromised. | accessdata.fda.gov |
| May 17, 2007 | 45464 | Not yet classified | Terminated | Edwards Vigilance II Continuous Cardiac Output/Oximetry/Volumetric (CCO/SvO2/CEDV) Monitor Model: VIG2/VIG2E Software Versions: 00.51,00.60, 00.61, 00.62, 00.63, 00.64, 00.67, 00.69, Edwards Lifesciences LLC., Irvine, CA | MAP offset errors: If users are "slaving" mean arterial pressure (MAP) from the bedside monitor into the Vigilance II Monitor for the purpose of the continuous calculation of systemic vascular resistance (SVR), at times, on some bedside monitors, the Vigilance II monitor may display a MAP offset of as much as 25mmHg. Since the MAP is used in calculations of | accessdata.fda.gov |
| March 19, 2007 | 45436 | Not yet classified | Terminated | Edwards Lifesciences LifeStent FlexStar Bilary Stent System Application, Model EX080801CD; 8 MM x 80 MM stent, 80 CM Delivery System, Lot FR6K0319, Edwards Lifesciences, LLC., Irvine, CA 92614 | Failure to deploy. | accessdata.fda.gov |
| June 21, 2006 | 35777 | Not yet classified | Terminated | EDWARDS VIGILANCE MONITORS (FORMERLY BAXTER VIGILANCE MONITORS) with software release 5.3 or earlier only. Patient monitor which measures cardiac output. Models: VG, VGS, VGS1, VGS2, VG2, & IVM. | Edwards Lifesciences Vigilance monitors with software release 5.3 or earlier may improperly cause the monitor to deliver power to the Continuous Cardiac Output (CCO) catheter without alerting the user to this situation. This can result in overheating and thermal damage to the CCO catheter and serious patient injury. | accessdata.fda.gov |
| April 28, 2005 | 32030 | Not yet classified | Terminated | Edwards LifeStent NT Self-Expanding Stent and Delivery System; Models: NT186901(D); NT187901(D); NT186902(D); NT187902(D); NT356901(D); NT357901(D);NT356902; NT357902(D) | Potential for deployment difficulties. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter, Continuous Flush
- All makers of Catheter, Embolectomy
- All makers of Percutaneously Delivered Prostheses And Tricuspid Valves
- All makers of Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter
- All makers of Aortic Valve, Prosthesis, Percutaneously Delivered
- All makers of Prosthesis, Mitral Valve, Percutaneously Delivered
Updated October 1, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.