INSPIRIS RESILIA AORTIC VALVE 11500A (REF 11500A21)Recalls & reported problems

Summary

The FDA's MAUDE database contains 223 adverse event reports that list this exact device (DI 00690103194975), received between Sep 24, 2021 and Sep 17, 2026 — classified as 1 death, 221 injuries, 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (108 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 223 reports, in the reporter's own words as published by the FDA.

• InjurySep 17, 2026Device Stenosis

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50808417 ↗
• InjurySep 14, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50764684 ↗
• InjurySep 11, 2026Intravalvular regurgitation

  Patient problems: Dyspnea

  MAUDE report 50742174 ↗
• InjurySep 11, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50740012 ↗
• InjuryMay 21, 2026Patient Device Interaction Problem

  IT WAS REPORTED AND LEARNED THROUGH THE INVESTIGATION THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF (B)(6) DUE TO CENTRAL REGURGITATION AND LEAFLET THICKENED (HALT). BASED ON THE CT REVIEW, THIS APPEARS TO BE AN EARLY VALVE DYSFUNCTION. THE LEAFLETS LOOK CLEARLY HYPOATTENUATED AND THICKENED, RAISING SUSPICION FOR LEAFLET PATHOLOGY - HALT - THAT MAY NOT BE PURELY STRUCTURAL DEGENERATION. THIS PATIENT PLAN OF CARE IS ANTICOAGULATION FOR APPROXIMATELY 3 MONTHS FOR POSSIBLE HALT AND HAVE EITHER A REPEAT ECHO OR CTA. IT WAS LEARNED PATIENT SUCCESSFULLY UNDERWENT TAVR WITH A 20MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS RECOVERING IN STABLE CONDITION POST-PROCEDURE.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 25249968 ↗
• InjuryMay 11, 2026Intravalvular regurgitation

  IT WAS REPORTED AND PER INVESTIGATION THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 9 MONTHS DUE TO INSUFFICIENCY. THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND ATRIAL FIBRILLATION (AFIB). THE PROCEDURE WAS PERFORMED SUCCESSFULLY WITH A 23MM 9755RSL2 TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Atrial Fibrillation; Dyspnea

  MAUDE report 25144549 ↗
• InjuryMay 10, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 11500A INSPIRIS RESILIA IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 5 MONTHS DUE TO UNKNOWN REASON. 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 25133670 ↗
• InjuryApr 17, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 21MM 11500A INSPIRIS VALVE UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF ONE (1) YEAR, FIVE (5) MONTHS DUE TO STENOSIS AND ENDOCARDITIS. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A INSPIRIS VALVE. THE PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED ON POD #12.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24917582 ↗
• InjuryApr 16, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 11500A 21MM AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 3 YEARS DUE TO SEVERE STENOSIS WITH INCREASED GRADIENT. THE PATIENT PRESENTED WITH CHF. A 23MM S3UR WAS IMPLANTED SUCCESSFULLY. PER MEDICAL RECORDS, PRE-OP ECHO SHOWS BIOPROSTHETIC AORTIC VALVE WITH INCREASED GRADIENT AND SEVERE AS. AVA 0.8 CM2, VMAX 4.3 M/S, MEAN PG 37 MMHG, MAX PG 72 MMHG. PRE-OP CARDIAC CATH, LEFT-SIDED CONGESTIVE HEART FAILURE CLASS II DUE TO VALVULAR DISEASE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24904155 ↗
• InjuryApr 7, 2026Insufficient Device Problem Information; Device Stenosis

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF (B)(6) DUE TO UNKNOWN REASON.

  Patient problems: Insufficient Information

  MAUDE report 24810868 ↗
• InjuryApr 6, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 1 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH HEART FAILURE . THE PROCEDURE WAS PERFORMED WITH A 26MM 9750TFX TRANSCATHETER VALVE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24796025 ↗
• InjuryApr 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 10 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11500A 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 24793773 ↗
• InjuryMar 25, 2026Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 2 YEARS, 4 MONTHS DUE TO SEVERE AORTIC INSUFFICIENCY AND AORTIC STENOSIS. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 20MM 9755RSL VALVE. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH SEVERE SYMPTOMATIC AORTIC INSUFFICIENCY. A 20MM 9755RSL VALVE WAS SUCCESSFULLY IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 24694453 ↗
• InjuryMar 20, 2026Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 6 YEARS, 9 MONTHS DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE DUE TO VALVULAR DISEASE. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24650970 ↗
• InjuryMar 16, 2026Insufficient Device Problem Information

  IT WAS REPORTED A 21MM 11500A AORTIC VALVE UNDERWENT REINTERVENTION AFTER IMPLANT DURATION OF APPROXIMATELY THREE (3) YEARS, DUE TO EARLY FAILURE OF UNKNOWN REASONS.

  Patient problems: Insufficient Information

  MAUDE report 24606786 ↗
• InjuryFeb 5, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 21MM 11500A VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 8 MONTHS DUE TO STREPTOCOCCUS SANGUINIS ENDOCARDITIS. THE EXPLANTED DEVICE WAS REPLACED WITH A 23MM 11500A VALVE. PER MEDICAL RECORDS, THE PATIENT WAS ADMITTED FOR NECK/BACK PAIN AND EVALUATED FOR RENAL MASS. CT CHEST SHOWED IRREGULAR LOW ATTENUATION THICKENING OF AORTIC LEAFLETS WITH HYPOMOBILITY, MORPHOLOGY CONCERNING FOR VEGETATIONS AND ENDOCARDITIS. ECHO SHOWED HYPOMOBILITY OF LEAFLETS AND STENOSIS. BLOOD CULTURES ARE POSITIVE. PATIENT UNDERWENT REDO AVR. INTRA-OP FINDINGS SHOWED SEVERE AMOUNT OF VEGETATION ON THE LEAFLETS. ONCE THE VALVE WAS EXCISED COULD CLEARLY SEE EXTENSIVE PANNUS/VEGETATION UNDER THE SEWING RING IN THE LVOT. THE ANNULUS AND ROOT WERE CAREFULLY DEBRIDED. A 23MM VALVE WAS THEN IMPLANTED WITH PLEDGETED SUTURES AND SECURED WITH COR KNOTS. THE VALVE WAS CONFIRMED TO BE WELL-SEATED. POST BYPASS TEE SHOWED NO REGURGITATION OR PVL, AND MG 7MMHG. THE PATIENT WAS TRANSPORTED TO THE ICU IN STABLE CONDITION AND DISCHARGED POD #7. HOSPITAL PATHOLOGY REPORT: FINAL DIAGNOSIS OF AORTIC PANNUS, FIBROUS TISSUE WITH EVIDENCE OF HEALIN

  Patient problems: Insufficient Information

  MAUDE report 24274056 ↗
• InjuryJan 13, 2026Degraded; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO DEGENERATION AND MODERATE STENOSIS. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT WAS STABLE POST-PROCEDURE AND WAS DISCHARGED ON POD# 1.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 24050384 ↗
• InjuryDec 30, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A INSPIRIS VALVE, IMPLANTED IN THE PULMONIC POSITION, UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 4 MONTHS DUE TO SEVERE STENOSIS AND MILD REGURGITATION. THE PATIENT PRESENTED WITH HEART FAILURE DUE TO VALVULAR DISEASE AND FATIGUE. THE TPVR WAS PERFORMED WITH A 23MM 9600TFX TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23926727 ↗
• InjuryDec 28, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  EDWARDS RECEIVED NOTIFICATION FROM GREECE THAT THIS INSPIRIS RESILIA VALVE MODEL 11500A21, IMPLANTED IN AORTIC POSITION, WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS AND 1 MONTH DUE TO A SUB-VALVULAR THROMBOSIS. THE THROMBOSIS WAS DIAGNOSED, AND CONFIRMED ON THE PRE-OPERATIVE ECHOCARDIOGRAPHY, AFTER 2 YEARS POST-IMPLANTATION OF THE SUBJECT DEVICE. PER PRODUCT EVALUATION FINDINGS, MODERATE HOST TISSUE OVERGROWTH WAS ALSO OBSERVED. THE PATIENT PRESENTED WITH MILD SHORTNESS OF BREATH PRIOR TO THE INTERVENTION AND WAS NOT ON ANTICOAGULANT MEDICATION AT THE TIME THE THROMBOSIS WAS DIAGNOSED. ANOTHER BIOPROSTHETIC VALVE WAS IMPLANTED IN REPLACEMENT. THE PATIENT DID NOT SUFFER ANY FURTHER INJURY DUE TO THIS EVENT AND WAS NOTED AS TO BE DISCHARGED IN VERY GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: Dyspnea; Thrombosis/Thrombus

  MAUDE report 23903381 ↗
• InjuryDec 23, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 6 MONTHS DUE TO STENOSIS. THE TAVR WAS SUCCESSFULLY PERFORMED WITH A 23MM 9755RSL VALVE. THE PATIENT WAS TAKEN TO RECOVERY WITH STABLE VITAL SIGNS POST PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 23885619 ↗
• InjuryDec 22, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT 21MM 11500A WAS EXPLANTED AFTER AN IMPLANT DURATION OF 10 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A KONECT AORTIC VALVED CONDUIT. THE IMPLANTATION DATA CARD INDICATED THAT THE PATIENT WAS TAKEN TO RECOVERY POST PROCEDURE. 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 23871996 ↗
• InjuryDec 20, 2025Insufficient Device Problem Information; Material Split, Cut or Torn; Insufficient Device Problem Information; Material Split, Cut or Torn

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 6 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 21MM 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 23860124 ↗
• InjuryDec 20, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE IN THE PULMONIC POSITION UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF FOUR (4) YEARS AND ONE (1) MONTH DUE TO REGURGITATION. THE PATIENT PRESENTED WITH FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS IN STABLE CONDITION POST PROCEDURE.

  Patient problems: Fatigue

  MAUDE report 23860112 ↗
• InjuryDec 19, 2025Device Stenosis; Device Stenosis

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 3 MONTHS DUE TO MODERATE STENOSIS. THE PATIENT PRESENTED WITH DYSPNEA AND FATIGUE. THE TAVR WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Dyspnea; Fatigue

  MAUDE report 23851133 ↗
• InjuryDec 16, 2025Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem; Calcified; Insufficient Device Problem Information; Patient Device Interaction Problem

  IT WAS REPORTED THAT A PATIENT WITH A 21MM 11500A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS, 9 MONTHS DUE TO LEAFLET CALCIFICATION AND PANNUS. THE EXPLANTED VALVE WAS REPLACED WITH AN UNKNOWN DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 23820948 ↗