EDWARDS INTUITY ELITE AORTIC VALVERecalls & reported problems across all models

We found 5 models of EDWARDS INTUITY ELITE AORTIC VALVE by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 205 adverse event reports in the FDA's MAUDE database, received between Jan 28, 2021 and Aug 3, 2026 — classified as 2 deaths, 203 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (88 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

Most reported EDWARDS INTUITY ELITE AORTIC VALVE problems

EDWARDS INTUITY ELITE AORTIC VALVE models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  heart-valve, non-allograft tissue
  60 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  heart-valve, non-allograft tissue
  1 death53 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  heart-valve, non-allograft tissue
  1 death52 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  heart-valve, non-allograft tissue
  24 reports
• EDWARDS INTUITY ELITE AORTIC VALVE 8300AB

  heart-valve, non-allograft tissue
  16 reports

Recent EDWARDS INTUITY ELITE AORTIC VALVE adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryAug 3, 2026Calcified

  It was learned through Implant Patient Registry and investigation that a patient with a 21mm 8300AB aortic valve was explanted after an implant duration of 8 years, due to calcification and stenosis. The explanted valve was replaced with a 23mm 11500A valve. Per medical records, the patient presented with heart failure NYHA class III and underwent a redo AVR. Intraop, the prior 21mm valve was removed, the annulus was sized and a 23mm 11500A valve was implanted with pledgeted sutures and secured with Cor-Knots. Post TEE showed no evidence of malfunction or leak. The patient was transferred to ICU in stable condition.Hospital pathology report: gross exam shows that the valve has 3 yellow calcified leaflets.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 source

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 50123920 ↗
• InjuryJul 27, 2026Patient Device Interaction Problem

  It was learned through receipt of medical records, that a patient with a 21mm 8300AB aortic valve implanted had complete heart block requiring permanent pacemaker on POD#2.Per medical records, the patient underwent TAVR explant with placement of a 21mm Edwards Intuity surgical valve. Post-operative course was complicated by CHB s/p PPM on POD#2. The patient was discharged home with HH on POD#5.

  Patient problems: Heart Block

  MAUDE report 50015504 ↗
• InjuryMay 16, 2026Degraded

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 5 MONTHS DUE TO DEGENERATION AND STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH, CHEST PAIN AND LIGHTHEADEDNESS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A VALVE. PATIENT WAS TRANSFERRED TO ICU AND DISCHARGED ON POD#3. 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

  MAUDE report 25195102 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 11 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 3300TFX VALVE. THE PATIENT EXPIRED 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 24736846 ↗
• InjuryMar 20, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 7 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A VALVE. THE PATIENT WAS IN 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: Aneurysm; Insufficient Information

  MAUDE report 24655981 ↗
• InjuryMar 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 8300AB 23MM AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 6 YEARS AND 4 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 11500A 25MM VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24653753 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 4 YEARS, 6 MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM11500A VALVE. THE PATIENT WAS IN 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: Endocarditis; Insufficient Information

  MAUDE report 24491536 ↗
• InjuryFeb 19, 2026Device Stenosis

  IT WAS REPORTED VIA CLINICAL SAFETY THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS, 11 MONTHS DUE TO STENOSIS. PATIENT PRESENTED WITH SHORTNESS OF BREATH AND FATIGUE. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. THE PATIENT TOLERATED THE PROCEDURE WELL WITHOUT COMPLICATION AND TRANSFERRED TO ICU IN STABLE CONDITION. THE PATIENT DISCHARGED ON POD#3.

  Patient problems: Dyspnea

  MAUDE report 24392782 ↗
• DeathJan 30, 2026Calcified

  IT WAS REPORTED THAT A PATIENT WITH A 25MM 8300AB AORTIC VALVE HAS BEEN PLACED UNDER EVALUATION FOR A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 8 YEARS DUE TO SEVERELY CALCIFIED LEAFLETS, SEVERE STENOSIS, AND REGURGITATION. THE PATIENT PRESENTED WITH SYMPTOMS OF HEART FAILURE. PER FCS, THE PATIENT IS BEING EVALUATED FOR A TRANSCATHETER VALVE REPLACEMENT AT PENROSE HOSPITAL. PER VCC/FCS, THE PATIENT PASSED AWAY THIS PAST WEEKEND ((B)(6) 2026) PRIOR TO PLANNED VIV PROCEDURE. HE HAD HEART BLOCK RELATED CARDIAC ARREST AND EXPIRED IN THE HOSPITAL.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 24223840 ↗
• InjuryJan 7, 2026Perivalvular Leak

  IT WAS REPORTED THAT A 8300AB 25MM AORTIC VALVE WAS EXPLANTED ON POD #7 DUE TO PERIVALVULAR LEAK. A 8300AB 27MM WAS IMPLANTED IN REPLACEMENT. AS REPORTED THE SIZERS HAD GOOD FIT IN THE ANNULUS, HOWEVER SURGEON STATED THERE WAS DIFFICULTY SEATING THE VALVE. PER MEDICAL RECORDS THE PATIENT INITIALLY UNDERWENT AVR AND CABG X 2. THE PATIENT HAD EXTENSIVE CALCIFICATION OF THE ASCENDING AORTA THAT WAS REMOVED ON THE LEFT SIDE. THERE WAS GOOD APPOSITION OF THE VALVE TO THE ANNULUS AND THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. POST-OPERATIVE ECHO SHOWED PERIVALVULAR LEAK. ON POD #7 THE PATIENT UNDERWENT REDO-AVR AND AORTIC ROOT ENLARGEMENT. THE LEAK WAS FOUND BETWEEN THE RIGHT AND THE LEFT CORONARY CUSP. THIS WAS MOSTLY PERIVALVULAR LEAK AROUND THE STENT OF THE VALVE. A NEW 8300AB VALVE WAS USED IN REPLACEMENT WITH GOOD APPOSITION TO THE ANNULUS. THE PATIENT WAS TRANSFERRED TO ICU IN STABLE CONDITION. PER PRODUCT EVALUATION CUSTOMER REPORTS OF DIFFICULTY SEATING AND PERIVALVULAR LEAK WERE UNABLE TO BE CONFIRMED THROUGH VISUAL OBSERVATIONS. AS RECEIVED, LEAFLET 1 HAD A 6MM CUT NEAR COMMISSURE 1 AND EDGES OF CUT APPEARED TO MATCH UP. REFERENCE MEASUREMENTS WERE TAKEN; THE EXTER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23992591 ↗
• InjuryDec 15, 2025Device Stenosis; Device Stenosis

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB INTUITY VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF SEVEN (7) YEARS, NINE (9) MONTHS DUE TO AORTIC STENOSIS AND REGURGITATION. THE PATIENT INITIALLY PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS VALVE. THE PATIENT WENT TO ICU POST SURGERY AND THEN WAS DISCHARGED HOME ON POD #7. 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

  MAUDE report 23811465 ↗
• InjuryNov 24, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A 21MM 8300AB INTUITY AORTIC VALVE IN AORTIC POSITION WAS DISABLED VIA VALVE IN VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 5 YEARS, 6 MONTHS DUE TO SEVERE AORTIC INSUFFICIENCY WITH PANNUS OBSERVED ON THE VALVE. THE PATIENT PRESENTED IN CHF/SHOCK. THE PROCEDURE WAS PERFORMED WITH A 20MM 9750TFX AND PATIENT WAS STABLE THROUGHOUT THE PROCEDURE. IT WAS LEARNED THROUGH PATIENT SUPPORT CENTER THAT THE PATIENT LATER EXPIRED.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 23638970 ↗
• InjuryNov 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY A 21MM 8300AB IMPLANTED IN THE AORTIC POSITION WAS EXPLANTED AFTER AN IMPLANT DURATION OF 8 YEARS AND 7 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 23MM 11500A BIOPROSTHETIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 23515363 ↗
• InjuryOct 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 25MM 8300AB INTUITY VALVE IN THE AORTIC POSITION UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF EIGHT (8) YEARS, FIVE (5) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11500A INSPIRIS 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 23382564 ↗
• InjuryOct 20, 2025Intravalvular regurgitation; Intravalvular regurgitation

  IT WAS REPORTED THAT A PATIENT WITH A 23MM 8300AB AORTIC VALVE UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 7 YEARS, 9 MONTHS DUE TO REGURGITATION. PATIENT PRESENTED WITH HEART FAILURE AND SHORTNESS OF BREATH. THE PROCEDURE WAS PERFORMED WITH A 23MM 9755RSL TRANSCATHETER VALVE. PATIENT WAS STABLE POST PROCEDURE. THIS IS A 4-YEAR-OLD MALE PATIENT.

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

  MAUDE report 23334127 ↗

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