INSPIRIS RESILIA AORTIC VALVE 11500A (REF 11500A23)Recalls & reported problems

Summary

The FDA's MAUDE database contains 404 adverse event reports that list this exact device (DI 00690103194982), received between Mar 16, 2021 and Sep 18, 2026 — classified as 2 deaths, 398 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (216 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, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 404 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50829480 ↗
• InjurySep 11, 2026Degraded

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50741758 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50740289 ↗
• InjurySep 8, 2026Device Stenosis

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50678917 ↗
• InjuryAug 7, 2026Calcified; Insufficient Device Problem Information

  It was reported that a patient with a 23mm 2700 111500A valve was explanted after an implant duration of 7 years, 3 months due to unknown reasons. The explanted valve was replaced with a 25mm 8300AB.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50179541 ↗
• InjuryAug 4, 2026Insufficient Device Problem Information

  It was learned through Implant Patient Registry that a 23mm 11500A Inspiris Resilia aortic valve was explanted after an implant duration of 1 year, 11 months due to unknown reason. Redo AVR was completed with a 25mm 11060A Konect valved conduit. 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 50136574 ↗
• InjuryJul 31, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  It was reported through Implant Patient Registry a 23mm 11500A aortic valve implanted two (2) years, six (6) months, was explanted due to unknown reasons. The explanted device was replaced with a 21mm 11500A aortic 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 50107614 ↗
• InjuryJun 1, 2026Device Dislodged or Dislocated

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED ON POD# 0 DUE TO PARAVALVULAR LEAK CAUSED BY SUTURE DEHISCENCE. THE EXPLANTED VALVE WAS REPLACED WITH ANOTHER 23MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT CABG X3 AND AVR. INTRAOPERATIVELY A 23MM 11500A VALVE WAS IMPLANTED IN SUPRA ANNULAR FASHION WITH PLEDGETED SUTURES AND COR-KNOTS WERE USED TO SECURE THE VALVE. TEE SHOWED WELL-SEATED VALVE WITH NO PVL AND LOW GRADIENTS. THE PATIENT TRANSFERRED TO THE ICU IN STABLE CONDITION. SEVERAL HOURS LATER THE PATIENT DEVELOPED TAMPONADE/ BLOOD COLLECTION OVER RA/LV AND RETURNED TO THE OPERATING ROOM. THE CHEST WAS REOPENED THERE WAS DIFFUSED COAGULOPATHY AND CLOT EVACUATED. TEE SHOWED LARGE NEW PARAVALVULAR LEAK ORIGINATING FROM THE RCC AND A SECOND FROM THE LCC. THESE LEAKS WERE NEW AND NOT APPARENT ON THE COMPLETION TEE FROM THE INITIAL SURGERY. GIVEN THIS UNEXPECTED AND UNEXPLAINED FINDING, SURGEON ELECTED REDO AVR INSTEAD OF PVL REPAIR DUE TO PATIENT'S AGE AND RELATIVE TISSUE QUALITY. THE AORTA WAS RE-OPENED, AND VALVE WAS INSPECTED AND REMOVED. THERE WERE TWO LOCATIONS WHERE THE VALVE HAD BECOME DETACHED

  Patient problems: Cardiac Tamponade

  MAUDE report 25353720 ↗
• InjuryMay 22, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF APPROXIMATELY 7 YEARS DUE TO STENOSIS AND INSUFFICIENCY. THE TAVR PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PER FIELD CLINICAL SPECIALIST, THE HEART TEAM BELIEVES THE PATIENT'S KIDNEY FAILURE CONTRIBUTED TO THE DETERIORATION OF THE SURGICAL VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 25255630 ↗
• InjuryMay 21, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT THIS DEVICE MODEL 11500A 23 MM AORTIC VALVE WAS EXPLANTED REPLACED WITH A 11500A 23 MM AFTER AN IMPLANT DURATION OF 2 YEARS, 9 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS ALIVE.

  Patient problems: Insufficient Information

  MAUDE report 25242453 ↗
• InjuryMay 11, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 11 MONTHS DUE TO STENOSIS. THE TAVR WAS COMPLETED WITH A 23MM 9755RSL TRANSCATHETER VALVE.

  Patient problems: Insufficient Information

  MAUDE report 25145210 ↗
• InjuryApr 29, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS AND 11 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11060A VALVED CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 25028865 ↗
• InjuryApr 24, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 11500A INSPIRIS RESILIA AORTIC VALVE IN AORTIC POSITION WAS EXPLANTED AND REPLACED WITH ANOTHER 21MM 11500A INSPIRIS RESILIA AORTIC VALVE AFTER AN IMPLANT DURATION OF 5 YEARS, 8 MONTHS DUE TO UNKNOWN REASON. REPORTEDLY, THE PATIENT WAS IN RECOVERY POST-OPERATIVE. 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 24984741 ↗
• DeathApr 21, 2026Adverse Event Without Identified Device or Use Problem

  EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY (IPR). 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". IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY (IPR) THAT THIS 11500A23 VALVE WAS EXPLANTED AT IMPLANT FROM THE AORTIC POSITION DUE TO AORTIC ROOT RUPTURE. AS REPORTED, DURING THE PROCESS OF IMPLANTING THE VALVE, A CALCIUM BAR WAS DISLODGED AND THE INTEGRITY OF THE ROOT, WHICH WAS VERY FRAGILE AND SIGNIFICANTLY CALCIFIED, WAS COMPROMISED. AS THE AORTIC ROOT WAS NOT SALVAGEABLE, IT WAS DECIDED TO ATTEMPT A BENTALL PROCEDURE WITH AN AORTIC CONDUIT VALVE. UNFORTUNATELY, THE PATIENT DID NOT SURVIVE. IT WAS NOTED THAT THE EDWARDS DEVICE WAS NOT A CONTRIBUTING FACTOR FOR THE DEA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24936614 ↗
• InjuryApr 8, 2026Calcified

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 6 MONTHS DUE TO SEVERE CALCIFICATION, DEGENERATION, AND SEVERE STENOSIS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 3300TFX VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE AND UNDERWENT REDO-REDO AVR AND MVR. A 23MM 3300TFX AORTIC VALVE WAS IMPLANTED WITH NON-PLEDGETED MATTRESS SUTURES. MVR WITH A NON-EDWARDS 31MM DURAN BAND. THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS DISCHARGED ON POD #7. HOSPITAL PATHOLOGY REPORT: GROSS EXAM ONLY OF AORTIC VALVE. ALL LEAFLETS ARE SEVERELY CALCIFIED WITH VERY LIMITED MOBILITY. THERE ARE NO CUSPAL TEARS, PERFORATIONS OR THROMBUS, AND NO PANNUS FORMATION.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24824481 ↗
• InjuryApr 8, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11060A VALVED CONDUIT. 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 24821108 ↗
• InjuryApr 3, 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 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 MONTHS AND 14 DAYS DUE TO ENDOCARDITIS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVE. THE PATIENT WAS IN RECOVERY POST PROCEDURE. IT WAS LEARNED THAT PATIENT LATER EXPIRED. THE EDWARDS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE PATIENT'S DEATH ACCORDING TO THE MD.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24783912 ↗
• InjuryApr 3, 2026Device Stenosis

  IT WAS REPORTED AND LATER LEARNED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS DUE TO STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE, SHORTNESS OF BREATH, AND FATIGUE. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS IN RECOVERY POST-OPERATIVE.

  Patient problems: Dyspnea; Fatigue; Heart Failure/Congestive Heart Failure

  MAUDE report 24776596 ↗
• MalfunctionMar 19, 2026

  WHEN DR WAS READY TO PLACE THE VALVE, THE LEAFLETS WERE NOTED TO NOT MEET OR FIT TOGETHER. THE VALVE WAS NOT USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24637970 ↗
• InjuryMar 18, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 5 YEARS AND 5 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11060A AORTIC CONDUIT VALVE.

  Patient problems: Dyspnea; Insufficient Information

  MAUDE report 24634939 ↗
• InjuryMar 14, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS AND 6 MONTHS DUE TO CALCIFICATION AND STENOSIS. THE PATIENT WAS PRESENTED WITH DYSPNEA AND FATIGUE. THE VALVE WAS REPLACED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 24601411 ↗
• InjuryMar 10, 2026Degraded; Inadequacy of Device Shape and/or Size

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 2 MONTHS DUE TO PPM, DEGENERATION, PVL, SEVERE VALVE STENOSIS AND MODERATE REGURGITATION. THE PATIENT PRESENTED WITH NYHA CLASS II SYMPTOMS. THE EXPLANTED VALVE WAS REPLACED WITH A 27MM 11500A VALVE. PER RECORDS PROVIDED, ON ECHO IT APPEARS THAT THE PATIENT HAS PPM WITH A SMALL PROTHESIS. ALTHOUGH THE LEAFLETS WERE MOVING, THERE IS A HIGH GRADIENT ACROSS HIS PROSTHETIC VALVE. THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE THE 23MM VALVE WAS CAREFULLY EXPLANTED. THE ANNULUS WAS DEBRIDED AND A 27MM 11500A VALVE WAS BROUGHT TO THE FIELD AND IMPLANTED AS REPLACEMENT. THE TRICUSPID VALVE WAS REPAIRED FOR MODERATE TO SEVERE TRICUSPID REGURGITATION. THE REPLACEMENT AORTIC VALVE SHOWED A 4MMHG GRADIENT WITH NO PARAVALVULAR LEAK. THE PATIENT CAME OFF BYPASS AND PROTAMINE WERE ADMINISTRATED. THE PATIENT WAS TRANSFERRED TO THE ICU IN A STABLE CONDITION POST PROCEDURE. EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHE

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24563594 ↗
• InjuryMar 5, 2026Device Stenosis

  IT WAS REPORTED THAT A 23MM 11500A INSPIRIS RESILIA AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 10 MONTHS DUE TO MODERATE STENOSIS AND REGURGITATION. THE PATIENT PRESENTED WITH CHEST PAIN. TAVR WAS COMPLETED WITH A 26MM 9755RSL TRANSCATHETER VALVE AND PATIENT WAS DISCHARGED IN STABLE CONDITION.

  Patient problems: Chest Pain

  MAUDE report 24519499 ↗
• InjuryMar 4, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH THE IMPLANT PATIENT REGISTRY THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 9 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A AORTIC VALVED CONDUIT. THE PATIENT WAS REPORTED TO BE IN RECOVERY POST-PROCEDURE. PER THE IMPLANTATION DATA CARD, THERE WAS NO DEFICIENCY IN THE ORIGINAL DEVICE. 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; Pseudoaneurysm

  MAUDE report 24510335 ↗
• InjuryFeb 13, 2026Calcified; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 23MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, AND 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A AORTIC 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: Dyspnea; Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24340187 ↗