MITRIS RESILIA Mitral ValveRecalls & reported problems across all models
Edwards Lifesciences LLC · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 199
- Deaths reported
- 4
- Injuries reported
- 193
- Recalls
- 0
We found 5 models of MITRIS RESILIA Mitral Valve by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 199 adverse event reports in the FDA's MAUDE database, received between Mar 12, 2022 and Sep 21, 2026 — classified as 4 deaths, 193 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (116 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported MITRIS RESILIA Mitral Valve problems
Device problems
- Insufficient Device Problem Information116
- Adverse Event Without Identified Device or Use Problem35
- Patient Device Interaction Problem21
- Perivalvular Leak13
- Fluid/Blood Leak11
- Intravalvular regurgitation11
- Patient-Device Incompatibility9
- Calcified8
Patient problems
- Insufficient Information137
- Endocarditis26
- Heart Failure/Congestive Heart Failure24
- Thrombosis/Thrombus15
- No Clinical Signs, Symptoms or Conditions9
- Dyspnea7
- Aortic Valve Insufficiency/ Regurgitation5
- Rupture4
MITRIS RESILIA Mitral Valve models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue58 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue2 deaths49 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue1 death37 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue29 reports
- MITRIS RESILIA Mitral Valve 11400MHeart-Valve, Non-Allograft Tissue1 death26 reports
Recent MITRIS RESILIA Mitral Valve adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 21, 2026Device Dislodged or Dislocated
Patient problems: Fever
MAUDE report 50848999 ↗InjuryJun 11, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED DEVICE WAS REPLACED WITH A 33MM 11400M MITRAL VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 25472455 ↗InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 33MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 33MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Endocarditis; Insufficient Information
MAUDE report 25398025 ↗InjuryApr 27, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 25006497 ↗InjuryApr 22, 2026Break; Device-Device Incompatibility
IT WAS REPORTED THAT A 27MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO FRAME DISTORTION CAUSED BY INTERFERENCE FROM THE PREVIOUSLY IMPLANTED TAV. ANOTHER 27MM 11400 MITRAL VALVE WAS IMPLANTED IN REPLACEMENT. PER MEDICAL RECORDS, THE PATIENT DEVELOPED MS UNDERWENT MIS-MVR. INTRAOPERATIVELY AFTER SECURING THE FIRST 27MM VALVE IN PLACE, THE SURGEON COULD SEE THAT THE FRAME WAS SOMEWHAT DISTORTED, MORE OVOID THAN CIRCULAR. THIS DISTORTION CAUSED SOME TENSION ON ONE OF THE LEAFLETS CAUSING A GAP BETWEEN THE ANTERIOR LATERAL LEAFLET AND THE OTHER 2 LEAFLETS. THERE WAS SIGNIFICANT TRANSVALVULAR REGURGITANT LEAK. DECISION WAS MADE TO CONVERT TO A STERNOTOMY APPROACH AND EXPLANT THE VALVE. THEN A NEW 27MM 11400M VALVE WAS IMPLANTED. AS THE LAST COR-KNOTS WERE BEING SECURED THE VALVE AGAIN TOOK A DISTORTED OVOID SHAPE - THE SAME DISTORTION OF THE LEAFLET AS SEEN PREVIOUSLY (1ST VALVE) OCCURRED. TO FIX THIS THE SURGEON RELEASED ONE OF THE SUTURES WITH ITS COR-KNOT. THE VALVE FRAME THEN BECAME MORE CIRCULAR AND THE GAP BETWEEN THE LEAFLETS DISAPPEARED. POST PROCEDURE TEE SHOWED EXCELLENT FUNCTION OF THE WELL-SEATED VALVE AND NO PVL OR TRANSVALVULAR REGURGITATION. THE PATIENT WAS TRANS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24955920 ↗InjuryApr 16, 2026Patient-Device Incompatibility
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 29MM 11400M MITRAL VALVE WAS EXPLANTED AT IMPLANT DUE TO LEFT CORONARY ARTERY OBSTRUCTION. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT 3RD TIME REDO MITRAL VALVE EXPLANT OF PRIOR NON-EDWARDS TRANSCATHETER VALVE. THERE WAS EXTENSIVE EROSION INTO ANNULUS FROM THE PRIOR NON-EDWARDS TRANSCATHETER VALVE WITH MALPOSITIONING IDENTIFIED. A 29MM 11400M MITRIS MITRAL VALVE WAS IMPLANTED AND TRICUSPID VALVE REPAIR WAS PERFORMED. UPON SEPARATING FROM CPB THERE WAS CONCERN ABOUT THE LEFT CIRCUMFLEX CORONARY ARTERY. CORONARY ANGIOGRAM WAS PERFORMED AND THE LEFT CIRCUMFLEX CORONARY ARTERY APPEARED TO BE COMPROMISED ADJACENT TO THE 11400M MITRAL VALVE PROSTHESIS. BYPASS WAS RESTARTED AND LEFT ATRIUM WAS REOPENED. THE 29MM 11400M VALVE WAS EXPLANTED AND A NEW 29MM 11400M VALVE WAS IMPLANTED. THE LEFT ATRIUM WAS REINFORCED IN SOME AREAS DUE TO THE DESTRUCTION OF THE PREVIOUS TRANSCATHETER VALVE. AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED FOR BIVENTRICULAR FUNCTION AND THEN ECMO WAS PLACED FOR CARDIOVASCULAR AND PULMONARY SUPPORT. HE PATIENT TOLERATED
Patient problems: Coronary obstruction/occlusion
MAUDE report 24906143 ↗InjuryApr 11, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS AND 9 DAYS DUE TO RECURRENT ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, THE PATIENT WAS ADMITTED FOR SEPSIS DUE TO E. FAECIUM AND MSSA BACTEREMIA, AND SACROILIITIS. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE PATIENT UNDERWENT REDO-TVR WITH A 31MM 11400M VALVE, REDO-MVR WITH A NON-EDWARDS VALVE. POST BYPASS TEE SHOWED BOTH VALVES WITH NO PVL. THE PATIENT TOLERATED THE PROCEDURE WITH NO IMMEDIATE COMPLICATIONS.
Patient problems: Endocarditis; Insufficient Information
MAUDE report 24849252 ↗InjuryMar 31, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 17 DAYS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 29MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL 'CUSTOMER COMPLAINT'. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 24749561 ↗InjuryMar 30, 2026Device Stenosis
IT WAS LEARNED THROUGH INVESTIGATION THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS AND 7 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT WAS PRESENTED WITH SHORTNESS OF BREATH. THE DEVICE USED WAS A 29MM SAPIEN RESILIA VALVE. ACCORDING TO THE MEDICAL RECORDS, AFTER TMVR WAS PERFORMED ON (B)(6) 2025 WITH ECMO. POSTOPERATIVELY, THE PATIENT ALSO HAD COMPLICATIONS SUCH ATRIAL FIBRILLATION, GIB, RENAL INFARCT AND PANCREATIC NECROSIS. THE PATIENT CONTINUED TO DETERIORATE AND WAS LATER LEARNED THAT THE PATIENT EXPIRED ON POD#27.
Patient problems: Dyspnea
MAUDE report 24737290 ↗InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11400M MITRAL VALVE IMPLANTED IN THE TRICUSPID POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS AND 23 DAYS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL CUSTOMER COMPLAINT. THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Endocarditis; Insufficient Information
MAUDE report 24719898 ↗InjuryMar 23, 2026Perivalvular Leak; Device Dislodged or Dislocated
IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 31MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 MONTH, 25 DAYS DUE TO SUTURES TORN OUT CAUSING SEVERE PVL. THE EXPLANTED VALVE WAS REPLACED WITH A 31MM 11400M VALVE. PER MEDICAL RECORDS, PATIENT PRESENTED WITH HEART FAILURE NYHA 3-4. ECHO REVEALED SEVERE PARAVALVULAR LEAK AND UNDERWENT SUCCESSFUL PLACEMENT OF AMPLATZER PLUG X2. HIS SYMPTOMS IMPROVED BUT CONTINUED TO HAVE A LEAK AND WAS BROUGHT BACK TO THE OR FOR REDO MVR MEDIAN STERNOTOMY. INTRA-OP TEE SHOWS SEVERE MITRAL REGURGITATION WITH A PARAVALVULAR JET AT P2. ON INSPECTION THERE WAS DEHISCENCE OF THE VALVE FROM THE ANNULUS AT P2. THE PREVIOUS STITCHES APPEARED TO HAVE BEEN APPROPRIATELY PLACED THROUGH THE ANNULUS BUT TORE THROUGH. THE PREVIOUS MV AND AMPLATZER DEVICES WERE REMOVED. A STRIP OF FELT WAS USED TO RECONSTRUCT THE POSTERIOR ANNULUS. ADDITIONAL STITCHES WERE PLACED AROUND THE ANNULS LEAVING PLEDGET ON THE ATRIAL SIZE EVERTING THE EDGE. A NEW 31MM 11400M WAS SEATED AND TIED INTO PLACE WITHOUT DIFFICULTY. POSTOP TEE SHOWED A WELL-SEATED VALVE IN THE MITRAL POSITION WITH NO LEAK, NO LVOT OBSTRUCTION, AND MG 2MMHG. THE PA
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 24659609 ↗InjuryMar 16, 2026Insufficient Device Problem Information
IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 11400M MITRAL VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 5 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11400M VALVE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 24608090 ↗InjuryFeb 27, 2026Break; Patient Device Interaction Problem; Material Split, Cut or Torn
EDWARDS RECEIVED INFORMATION THAT A 27MM 11400M MITRAL PERICARDIAL VALVE, IMPLANTED APPROXIMATELY FOUR (4) YEARS, WAS EXPLANTED DUE TO MITRAL REGURGITATION(MR). THE PATIENT PRESENTED WITH HEMOLYTIC ANEMIA AND CHANGES IN URINE COLOR AND SYMPTOMS OF ANEMIA. THE DEVICE WAS EXPLANTED AND REPLACED WITH A NON-EDWARDS VALVE, EPIC. UPON RE-DO MITRAL VALVE REPLACEMENT (MVR), PERFORATIONS WERE FOUND IN TWO PLACES ON THE VALVE LEAFLET. NO CALCIFICATION WAS FOUND. IT WAS THOUGHT THAT THE PERFORATIONS HAD CAUSED MR. THE PATIENT STATUS WAS REPORTED AS STABLE CONDITION.
Patient problems: Anemia; Hemolysis; Hemolytic Anemia
MAUDE report 24474893 ↗InjuryFeb 27, 2026Insufficient Device Problem Information
IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11400M MITRAL VALVE IN MITRAL POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 29MM 11400M MITRAL VALVE AFTER AN IMPLANT DURATION OF 1 YEAR, 1 MONTHS, AND 10 DAYS. REASON FOR REINTERVENTION WAS NOT PROVIDED. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 24472296 ↗InjuryFeb 26, 2026Perivalvular Leak
IT WAS LEARNED VIA IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 11400M 31MM MITRAL VALVE UNDERWENT A PLUG PLACEMENT PROCEDURE AFTER AN IMPLANT DURATION OF 4 MONTHS DUE TO PERIVALVULAR LEAK. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT." THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE.
Patient problems: Insufficient Information
MAUDE report 24456947 ↗
Other Edwards Lifesciences LLC products
- Edwards SAPIEN 315 models · 6,905 reports · 1 recall
- EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (THV)4 models · 2,986 reports · 1 recall
- Edwards SAPIEN 3 Ultra Transcatheter Heart Valve3 models · 2,147 reports
- INSPIRIS RESILIA AORTIC VALVE6 models · 1,305 reports
- EDWARDS ESHEATH INTRODUCER SET4 models · 973 reports
- SAPIEN 3 Ultra RESILIA4 models · 881 reports
- SAPIEN 3 Ultra System3 models · 876 reports
- FOGARTY32 models · 486 reports · 3 recalls
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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