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Edwards Lifesciences LLC: FDA-registered device maker in Draper, UT, United States, 10 510(k) clearances and 7 PMA approvals

Name: Edwards Lifesciences LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Edwards Lifesciences LLC is registered with the FDA (registration 3008500478) in Draper, UT, United States. It lists 22 device types. The FDA files 10 510(k) clearances and 7 PMA approvals under its listings, the newest dated April 17, 2026. 31 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Edwards Lifesciences LLC

FDA registration number: 3008500478
FEI number: 1713910
Address: 12050 Lone Peak Parkway, Draper, UT, United States, 84020
Owner or operator: Edwards Lifesciences LLC (9040666)
Roles: Manufacturer
First device listed: April 4, 1997
Registered through: 2027
Brand names listed: Ascendra + Introducer Sheath Set, Ascendra Balloon Aortic Valvuloplasty Catheter, Ascendra+ Delivery System, Ascendra+ System, Crimp Stopper, ECLIPTIS System Sizing Guide, EDWARDS INTUITY Elite Valve System, EDWARDS MC3 TRICUSPID ANNULOPLASTY RING and more

Devices it lists

Device	Product code	Class	Role	Source
Aortic Valve, Prosthesis, Percutaneously Delivered	NPT	3	Manufacturer	accessdata.fda.gov
Balloon Aortic Valvuloplasty	OZT	2	Manufacturer	accessdata.fda.gov
Cardiovascular Delivery Catheter System Positioning And Stabilization Device	QWA	1	Manufacturer	accessdata.fda.gov
Catheter Introducer Kit	OFD	2	Manufacturer	accessdata.fda.gov
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	2	Manufacturer	accessdata.fda.gov
Clamp, Vascular	DXC	2	Manufacturer	accessdata.fda.gov
Handle, Scalpel	GDZ	1	Manufacturer	accessdata.fda.gov
Heart-Valve, Non-Allograft Tissue	LWR	3	Manufacturer	accessdata.fda.gov
Holder, Heart-Valve, Prosthesis	DTJ	1	Manufacturer	accessdata.fda.gov
Hook, Surgical, General & Plastic Surgery	GDG	1	Manufacturer	accessdata.fda.gov
Instruments, Surgical, Cardiovascular	DWS	1	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Mitral Valve Repair Devices	NKM	3	Manufacturer	accessdata.fda.gov
Percutaneously Delivered Prostheses And Tricuspid Valves	NPW	3	Manufacturer	accessdata.fda.gov
Prosthesis, Mitral Valve, Percutaneously Delivered	NPU	3	Manufacturer	accessdata.fda.gov
Pulmonary (Pulmonic) Valvuloplasty Catheters/Percutaneous Valvuloplasty Catheter	OMZ	2	Manufacturer	accessdata.fda.gov
Pulmonary Valve Prosthesis Percutaneously Delivered	NPV	f	Manufacturer	accessdata.fda.gov
Retractor	GAD	1	Manufacturer	accessdata.fda.gov
Ring, Annuloplasty	KRH	2	Manufacturer	accessdata.fda.gov
Sizer, Heart-Valve, Prosthesis	DTI	1	Manufacturer	accessdata.fda.gov
Snare, Surgical	GAE	1	Manufacturer	accessdata.fda.gov
Tricuspid Valve Repair Device, Percutaneously Delivered	NPS	3	Manufacturer	accessdata.fda.gov

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
April 17, 2026	K254279	Edwards eSheath+ introducer set	DYB	Substantially Equivalent	Edwards Lifesciences	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
July 1, 2010	K093877	RETROFLEX 3 INTRODUCER SHEATH SET, MODELS 9120S23 AND 9120S26	DYB	Substantially Equivalent	Edwards Lifesciences, LLC	accessdata.fda.gov
January 14, 2010	K093730	PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24)	DWF	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
May 16, 1991	K910221	RMI VASCULAR TOURNIQUET KIT	DXC	Substantially Equivalent	Research Medical, Inc.	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
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
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

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
January 22, 2019	81924	Class II	Terminated	Edward Lifesciences, Edwards Commander Delivery System: Model Number UDI Number 9600LDS20A (US) 00690103193930 9600LDS20J 00690103194852 9600LDS23A (US) 00690103193947 9600LDS23J 00690103194869 9600LDS26A (US) 0069010319	This action has been initiated to address complaint reports received for crimp balloon and inflation balloon component separation during TAVR procedures.	accessdata.fda.gov
March 30, 2018	79650	Class II	Terminated	Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100. Designed to occlude the ascending aorta.	Possible leak at distal open end of the strain relief, which causes medical staff to continue adding inflation fluid to maintain balloon pressure for adequate occlusion of the ascending aorta.	accessdata.fda.gov
July 21, 2017	78738	Class I	Terminated	Certitude Delivery System and any associated Multipacks Models - 9600CT20A, 9600CT23A, 9600CT26A, 9600CT29A Product Usage: The Edwards Certitude Delivery System is used for delivery of the Edwards SAPIEN 3 transcatheter	A component in the Certitude Loader may have a molding overflow defect that could detach during advancement of the delivery system and potentially embolize from the loader into the patient.	accessdata.fda.gov
November 4, 2015	72667	Class II	Terminated	Thin-Flex Venous Cannula, Model Number:TF292902A	Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.	accessdata.fda.gov
August 26, 2015	72046	Class II	Terminated	ThruPort Knot Pusher. This device is sold individually (Model KP1) and as part of the ThruPort Valve Placement Pack (Model VPP). packaged sterile and non-pyrogenic in a sealed, peel-type pouch. The Knot Pusher is a steri	The configuration of the slot at the tip of the knot pusher may inhibit intended ease of use. Fraying or splitting of the suture could occur, which could compromise the integrity of the suture knot.	accessdata.fda.gov
May 5, 2015	71269	Class II	Terminated	Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch For use in patients u	Potential device damage on the strain relief near the hub area, which may result in blood leakage.	accessdata.fda.gov
March 23, 2015	70820	Class II	Terminated	Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC, Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, F	Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.	accessdata.fda.gov
October 8, 2014	69565	Class II	Terminated	Edwards Lifesciences Vent Catheters,. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Model Numbers: E061, E060, PE062, EM012 Atrial Vent Catheters are intended for venting the left heart during short-te	Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for disruption of the white plastic coating on the stylet.	accessdata.fda.gov
April 9, 2014	67983	Class II	Terminated	Edwards Lifesciences Fem-Flex II Arterial and femoral Cannulae, arterial cannula sizes 16, 18 and 20 French, models: FEMII016A, FEMII016AS, FEMII018A, FEMII018AS, FEMII020A, and FEMII020AS.	Potential for separation of dilator tips.	accessdata.fda.gov
January 20, 2014	67362	Class II	Terminated	Crimper Model 9100CR26 The Crimper is indicated for use in preparing the Edwards SAPIEN Transcatheter Heart Valve for implantation.	Edwards Lifesciences is recalling two lot numbers of the 26mm transcatheter heart valve crimper because they may not open sufficiently when the handle is rotated in the full open position. As a result, user may have difficulty fitting a 26mm Sapien transcatheter heart valve into the crimper orifice when preparing the valve for crimping.	accessdata.fda.gov
November 20, 2013	66934	Class III	Terminated	Edwards Lifesciences Ergonic Double Acting DeBakey Forceps with Narrow Straight Tip. Model Number ERGF01330. The Edwards Surgical Instruments are designed to perform specialized functions in specific cardiac surgical or	Edwards Lifesciences is recalling one lot of Ergonic instrument due to mislabeling. Ergonic scissors standard curved labeled as a Double Acting DeBakey forcep. Edwards control confirmed that the laser etching on the device was incorrect.	accessdata.fda.gov
September 16, 2013	66305	Class I	Terminated	Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device	Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip.	accessdata.fda.gov
August 26, 2013	66112	Class II	Terminated	Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situatio	Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation.	accessdata.fda.gov
July 30, 2013	65838	Class II	Terminated	Edwards Lifesciences Anastaflo Intravascular Shunt, Model code IVS12512, IVS1512, IVS17512, IVS2012, IVS2512, IVS3012, IVS1530, IVS2030 and IVS25 Anastaflo shunts are intended for use in preventing ischemia by shunting a	Edwards Lifesciences is recalling certain lots of the Anastaflo intravascular Shunt due to concerns of excessive adhesive on the shunt body that may interfere with suturing of by-pass grafts.	accessdata.fda.gov
July 16, 2013	65744	Class II	Terminated	Edwards EndoReturn Arterial Cannula, model ER21B and ER23B Product Usage: The ThruPort EndoReturn arterial cannula kit (with or without hemostasis valve), an introducer, a guidewire,and a connector hub. The ThruPort cath	Edwards Lifesciences is recalling certain lots of the EndoReturn Arterial Cannula that were built with an incorrect component. This component can create a performance problem with the IntraClude IntraAortic Occlusion device.	accessdata.fda.gov
June 19, 2013	65492	Class II	Terminated	Edwards Lifesciences Suction Wand, models S099 and S0998B Suction wands are intended for hand held use and pericardial sumps are intended for stationary use in removing excess fluid from the surgical field.	Edwards is recalling certain lots of Rigid Suction Wands because they discovered plastic particulate inside the sterile pouch and within the internal diam ether of the wand.	accessdata.fda.gov
May 14, 2013	65173	Class II	Terminated	QuickDraw Venous Cannula with Insertion Kit. ThruPort Systmes. Models QD22 (22 Fr) and QD25 (25 Fr). The product is packaged sterile and non-pyrogenic in a sealed, peel-type pouch. Two pouches (cannula and accessories) g	Edwards is recalling the QuickDraw Venous Cannula due to complaints of cannula separation during withdrawal of the device when the Percutaneous insertion method is used.	accessdata.fda.gov
March 26, 2013	64747	Class II	Terminated	Edwards Lifesciences Crimpers, Model 9100CR23. The Crimpers are used to crimp the transcatheter heart valve onto the delivery system prior to use.	Holes in the sterile barrier pouch may be caused by handling of the device during manufacturing or once pouches have been removed from the unit box and stored on the shelf by customers.	accessdata.fda.gov
March 14, 2013	64782	Class II	Terminated	Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass	Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly sealed pouches may result in a sterility barrier breach.	accessdata.fda.gov
January 25, 2013	64221	Class II	Terminated	Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9. Product Usage: The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire	Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.	accessdata.fda.gov
June 6, 2012	52194	Class II	Terminated	Edwards Lifesciences Rigid Suction Wand, sterile. Model numbers S033 and SPC2081. Product Usage: These suction catheters are typically used to remove fluid on the external surface of the heart during cardiac surgery and	Edwards is recalling Suction Wand models SPC2081 and S033 because the plastic tip attached to the metal suction wand may become detached during routine use.	accessdata.fda.gov
June 15, 2011	59135	Not yet classified	Terminated	Endopledge Sinus Catheter Kit, REF: EP, 9 Fr x 18.9", Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA. Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronar	Possibility of separation of the introducer sheath from the hub on Coronary Sinus Catheters.	accessdata.fda.gov
January 21, 2011	57951	Not yet classified	Terminated	Edwards Aortic Perfusion Cannula with Duraflow Coating, REF: DARH201190TA, 20 Fr. x 28 cm, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614. The cannula perfuses blood to the ascending aorta during short-term (<6 h	Bonding of the tip to the aortic cannula tubing may decline over time and may contribute to a drop in bond strength. Possible tip separation.	accessdata.fda.gov
December 3, 2010	57522	Not yet classified	Terminated	EndoPlege Sinus Catheter Kit, REF EP, 9 Fr x 18.9", Contains Phthalates, Sterile EO, Sterile R, Edwards Lifesciences LLC, Irvine, CA 92614. The EndoPlege coronary sinus catheter is a three-lumen, 9 Fr catheter with an el	Defective product may result in the silicone valve becoming dislodged from the introducer which can result in injury.	accessdata.fda.gov
October 19, 2010	57143	Not yet classified	Terminated	Edwards Protection Cannulae - Monitoring and Infusion Set, Model ISP3147, Sterile EO, Edwards Lifesciences LLC, One Edwards Way, Irvine, CA 92614	Monitoring and Infusion Set connectors may break during manipulation.	accessdata.fda.gov
September 24, 2009	53576	Not yet classified	Terminated	EndoClamp aortic catheter. Label reading in part: "*CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile R, Edwards Lifesciences LLC Irvine, CA*". The device is a 10.5Fr wirewound, three-lu	Balloon catheters were spontaneously rupturing during use.	accessdata.fda.gov
November 26, 2008	50502	Not yet classified	Terminated	Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in patients undergoing car	Balloon rupture: Catheter balloon may rupture during cardiopulmonary bypass procedure. For further information, please telephone Edwards Lifesciences Research Medical, Inc. at.	accessdata.fda.gov
July 14, 2008	49049	Not yet classified	Terminated	Thin-Flex Venous Return Cannulae, 33/43 FR. x 39 cm, REF TF3343O, Sterile EO, Edwards Lifesciences LLC, Irvine, CA 92614 Intended for cannula drainage of the superior and inferior vena cava during extracorporeal circulat	Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.	accessdata.fda.gov
February 25, 2008	47204	Not yet classified	Terminated	Edwards Lifesciences LLC, Fem-Flex II Femoral Venous Cannula, 12 Fr. x 11.5 cm, REF FEMII012V, Cardiopulmonary bypass tubing.	Femoral Venous Cannula was color coded as an arterial cannula. This problem could result in a minor delay in the procedure. In the worst case, this product could be connected incorrectly during bypass, which would result in a more significant delay and has the potential to result in a permanent injury.	accessdata.fda.gov
April 18, 2006	35291	Not yet classified	Terminated	Aortic Perfusion Cannula with plastic tip, 22 Fr. x 28 cm Edwards Lifesciences	Due to potential embrittlement of the plastic tip which may crack or separate during use.	accessdata.fda.gov
November 19, 2004	30623	Not yet classified	Terminated	EMBOL-X Slim Access Device / Aortic Cannula 24 Fr X 11''.	Aortic cannula may delaminate and leak where it is bonded to the tip. This could occur during cardiopulmonary bypass surgery.	accessdata.fda.gov

Compare with other makers

Updated July 29, 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.