KONECT RESILIARecalls & reported problems across all models

We found 5 models of KONECT RESILIA by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Sep 17, 2021 and Sep 12, 2026 — classified as 1 death, 95 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (68 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 KONECT RESILIA problems

KONECT RESILIA models

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

• KONECT RESILIA 11060A

  Heart-Valve, Non-Allograft Tissue
  29 reports
• KONECT RESILIA 11060A

  Heart-Valve, Non-Allograft Tissue
  23 reports
• KONECT RESILIA 11060A

  Heart-Valve, Non-Allograft Tissue
  1 death22 reports
• KONECT RESILIA 11060A

  Heart-Valve, Non-Allograft Tissue
  18 reports
• KONECT RESILIA 11060A

  Heart-Valve, Non-Allograft Tissue
  6 reports

Recent KONECT RESILIA adverse event reports

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

• InjurySep 12, 2026Insufficient Device Problem Information

  Patient problems: Insufficient Information

  MAUDE report 50745189 ↗
• InjuryJun 18, 2026Insufficient Device Problem Information

  IT WAS REPORTED VIA THE IMPLANT PATIENT REGISTRY THAT A 11060A 25MM AORTIC VALVED CONDUIT WAS EXPLANTED AND REPLACED WITH A 11060A 25MM AFTER AN IMPLANT DURATION OF 3 YEARS, 4 MONTHS DUE TO UNKNOWN REASONS. THE PATIENT WAS ALIVE. 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 25552819 ↗
• InjuryMay 20, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 DAY DUE TO UNKNOWN REASON. THE PROVIDED MEDICAL RECORDS DID NOT MENTION THE 27MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH RIGHT JAW PAIN, CHEST PAIN, AND BLE WEAKNESS. THE PATIENT WAS FOUND TO HAVE CT EVIDENCE OF A TYPE A AORTIC DISSECTION. REDO STERNOTOMY WAS PERFORMED FOR THE AORTIC DISSECTION REPAIR AND AORTIC VALVE REPLACEMENT WITH A 25MM KONECT VALVED CONDUIT. INTRA-OPERATIVELY, ONCE THE AORTA WAS UNCLAMPED, THE PATIENT EXPERIENCED V-FIB REQUIRING INTERNAL DEFIB X6. INTRA-OP TEE NOTED A DILATED LV WITH NORMAL BIVENTRICULAR FUNCTION. THE 25MM KONECT VALVED CONDUIT WAS IMPLANTED SUCCESSFULLY WITHOUT COMPLICATION. THE PATIENT WAS TAKEN TO THE ICU POST PROCEDURE. THE PATIENT WAS DISCHARGED POD #4. 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

  Patient problems: Insufficient Information

  MAUDE report 25235535 ↗
• InjuryApr 3, 2026Insufficient Device Problem Information

  IT WAS LEARNED VIA THE PATIENT REGISTRY THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT UNDERWENT REDO AORTIC VALVE REPLACEMENT AFTER AN IMPLANT DURATION OF TWO (2) YEARS, TWO (2) MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 29MM 11060A AORTIC 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 24779235 ↗
• InjuryMar 31, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS DUE TO CUTIBACTERIUM ACNES ENDOCARDITIS OF THE AVC GRAFT. THE EXPLANTED DEVICE WAS REPLACED WITH ANOTHER 27MM 11060A AORTIC VALVED CONDUIT. PER MEDICAL RECORDS, THE PATIENT PRESENTED IN ER WITH WORSENING FATIGUE AND HYPOTENSION. ECHO SHOWED 27MM AVC WITH NORMAL STRUCTURE AND FUNCTION, MG 8MMHG AND NO PVL. CHEST CT REVEALED PERIAORTIC SEROMA/ABSCESS. THE PATIENT UNDERWENT REDO AVR AND BENTALL PROCEDURE. INTRAOP, SUBSTERNAL POCKET OF THICK WHITE CREAMY PUS WAS ENCOUNTERED, NO ABSCESS IN THE ANNULAR AREA, CULTURES WERE SENT. DRAINAGE OF ABSCESSES PERI-GRAFT AND BELOW XIPHOID. AFTER COPIOUS IRRIGATION/DEBRIDEMENT ANOTHER 27MM AVC WAS IMPLANTED WITH MATTRESS PLEDGETED SUTURES AND SECURED WITH COR-KNOTS. THERE WAS EXCELLENT FUNCTION OF THE VALVE. IT WAS NOTED THERE WAS NO FREE FLUID COMING FROM THE DEPTH OF THE DISSECTION, SUGGESTING A POTENTIAL LYMPHATIC LEAK/LYMPHOCELE. WHILE WEANING FROM CPB, PROFOUND VASOPLEGIA, COAGULOPATHY, AND MODERATE RV DYSFUNCTION. AFTER LONG PERIOD OF HEMOSTASIS, THE PATIENT WAS TAKEN TO ICU IN GOOD CONDI

  Patient problems: Insufficient Information

  MAUDE report 24746464 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 25MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AT IMPLANT DUE TO BLEEDING. THE EXPLANTED DEVICE WAS REPLACED WITH AN UNKNOWN DEVICE. THE PATIENT INITIALLY WAS TAKEN TO THE OR TO TREAT ACUTE TYPE A AORTIC DISSECTION. THE NATIVE AORTIC VALVE WAS REPLACED WITH A 25 MM 11060A VALVED CONDUIT THAT WAS SEATED AND SECURED WITH COR-KNOT. AFTER THE PATIENT WAS WEANED FROM BYPASS AND DECANNULATED, THERE WAS HIGH VOLUME ARTERIAL BLEEDING FROM NEAR THE AORTIC ROOT. THE PATIENT WENT BACK ON BYPASS, AND THE TEAM WAS NOT ABLE TO VISUALIZE THE SOURCE OF BLEEDING. IT WAS DECIDED TO REARREST THE HEART AND TOOK THE ROOT APART AND THE TIP OF A COR-KNOT WAS VISIBLE NEAR THE LEFT MAIN. THE VALVED CONDUIT, COR-KNOT AND PLEDGETS WERE REMOVED AND ANOTHER DEVICE WAS PLACED IN REPLACEMENT HAND TIED RATHER THAN USING COR-KNOT. THE PATIENT CAME OFF BYPASS, AND THE BLEEDING SITE WAS FIXED, HOWEVER; THERE WAS TORRENTIAL COAGULOPATHIC BLEEDING FROM ALL SITES. THE TEAM SPENT SEVERAL HOURS PACKING AND DRYING UP AND THE PATIENT RETURNED TO THE ICU IN CRITICAL CONDITION. RESUSCITATION ATTEMPTS WERE PERFORMED IN THE OR AND ICU, HOWEVER, THE PATI

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24735848 ↗
• InjuryMar 14, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 11060A 29MM VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 3 YEARS AND 10 MONTHS DUE TO UNKNOWN REASON. THE VALVED CONDUIT WAS REPLACED WITH ANOTHER 29MM 11060A CONDUIT.

  Patient problems: Insufficient Information

  MAUDE report 24601419 ↗
• InjuryMar 9, 2026Perivalvular Leak; Device Dislodged or Dislocated; Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND INVESTIGATION THAT A 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF FOUR (4) YEARS, AND NINE (9) MONTHS DUE TO UNKNOWN REASON. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 11060A 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: Chest Pain; Insufficient Information

  MAUDE report 24553373 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 11 MONTHS DUE TO UNKNOWN REASON. THE VALVE WAS REPLACED WITH A 27MM 11500A BIOPROSTHETIC VALVE.

  Patient problems: Insufficient Information

  MAUDE report 24539303 ↗
• InjuryMar 6, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEARS, 8 MONTHS DUE TO UNKNOWN REASONS. 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 24531041 ↗
• InjuryMar 2, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A 29MM 11060A AORTIC VALVE WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR AND 5 MONTHS DUE TO BACTERIAL ENDOCARDITIS. THE VALVE WAS REPLACED WITH A 29MM 11060A AORTIC VALVE. PER MEDICAL RECORDS, THE PATIENT UNDERWENT COMMANDO PROCEDURE WITH REDO-AVR WITH ROOT REPLACEMENT USING 29MM 11060A VALVED CONDUIT AND ASCENDING AORTIC REPLACEMENT, REDO-MVR WITH NON-EDWARDS VALVE, RECONSTRUCTION OF THE AORTO-MITRAL CONTINUITY AND LA DOME WITH A PATCH AND CORONARY BUTTON REIMPLANTATION. THE PATIENT WAS TRANSFERRED TO ICU IN CRITICAL CONDITION.

  Patient problems: Endocarditis; Insufficient Information

  MAUDE report 24478519 ↗
• InjuryFeb 18, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY THAT A PATIENT WITH A 27MM 11060A AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 2 YEARS, 2 MONTHS DUE TO UNKNOWN REASONS. THE EXPLANTED VALVE WAS REPLACED WITH A 25MM 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 24380105 ↗
• InjuryFeb 17, 2026Insufficient Device Problem Information

  IT WAS LEARNED THROUGH IMPLANT PATIENT REGISTRY AND MEDICAL RECORDS THAT A PATIENT WITH A 25MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT WAS EXPLANTED AFTER AN IMPLANT DURATION OF 1 YEAR, 3 MONTHS DUE TO AORTIC ROOT PSEUDOANEURYSM. THE PATIENT PRESENTED WITH CHEST PAIN. THE EXPLANTED VALVE WAS REPLACED WITH A 23MM 11060A VALVED CONDUIT. THE PATIENT WAS TRANSFERRED TO THE CICU IN CRITICAL, BUT STABLE CONDITION. THE PATIENT WAS DISCHARGED POD #7. PER MEDICAL RECORDS, THE PATIENT IS A KNOWN CASE OF LOEYS-DIETZ SYNDROME WHO PRESENTED WITH CHEST PAIN. BLOOD CULTURE WAS POSITIVE FOR MSSA BACTEREMIA. TEE (09/18/25) REVEALED RECURRENT SCENDING AORTA AND AORTIC ROOT PSEUDOANEURYSM IN ADDITION TO ABSCESS NEAR AORTIC GRAFT. REDO STERNOTOMY WAS PERFORMED TO REPLACE THE PATIENT'S PREVIOUS 25MM RESILIA WITH A 23MM RESILIA. INTRA-OPERATIVELY, THE PATIENT WAS FOUND TO HAVE TWO ACTIVE BLEEDING SITES (PSEUDOANEURYSM) WITH NO OBVIOUS SIGN OF INFECTION. THE 23MM 11060A KONECT RESILIA AORTIC VALVED CONDUIT WAS IMPLANTED SUCCESSFULLY AND THE PATIENT TOLERATED THE PROCEDURE WELL. THE PATIENT WAS TRANSFERRED TO THE CICU IN CRITICAL, BUT STABLE CONDITION. THE PATIENT WAS DISCHARGED POD #7. PER PATHOLOGY

  Patient problems: Insufficient Information

  MAUDE report 24371080 ↗
• InjuryJan 30, 2026Patient-Device Incompatibility

  IT WAS LEARNED THROUGH MEDICAL RECORDS RECEIVED THAT AFTER IMPLANT OF A 23MM 11060A AORTIC VALVED CONDUIT (AVC), THERE WAS SEVERE NATIVE MITRAL VALVE REGURGITATION. THE NATIVE MITRAL VALVE WAS REPLACED WITH A 25MM MITRIS VALVE. THE PATIENT UNDERWENT A REDO AVR FOR ENDOCARDITIS. A 23MM 11060A AVC WAS IMPLANTED IN REPLACEMENT AND THE VALVE ITSELF SEATED WELL. WHILE WEANING FROM BYPASS IT BECAME APPARENT THE NATIVE MITRAL VALVE WAS SEVERELY REGURGITANT, LIKELY SECONDARY TO ANTERIOR LEAFLET OF THE ANNULUS WAS RESTRICTED OR FORESHORTENED AS PART OF THE IMPLANTATION OF THE AVC IN THE LVOT. THE DECISION WAS MADE TO REPLACE THE MITRAL VALVE, TRANSSEPTAL APPROACH WAS USED BUT STILL DIFFICULTY VISUALIZING THE ANTERIOR LEAFLET. A 25MM MITRIS VALVE WAS IMPLANTED WITH PLEDGETED SUTURES AND SECURED WITH COR-KNOTS. POST CPB TEE SHOWED 23MM AVC AND THE 25MM MITRIS VALVE WELL-SEATED WITH NORMAL FUNCTION AND NO PVL. WHILE WEANING FROM BYPASS THERE WAS EXTENSIVE BLEEDING FROM THE PROXIMAL END OF THE AORTIC ROOT REPLACEMENT SUTURE LINE. DESPITE ATTEMPTS TO GAIN HEMOSTASIS, THE HEMORRHAGE WAS UNSURVIVABLE. THE DECISION WAS MADE TO STOP FURTHER RESUSCITATION AND THE PATIENT EXPIRED IN THE OR.

  Patient problems: Mitral Valve Insufficiency/ Regurgitation

  MAUDE report 24226224 ↗
• InjuryJan 29, 2026Device Stenosis

  IT WAS REPORTED AND LEARNED THROUGH MEDICAL RECORDS THAT A PATIENT WITH A 29MM 11060A AORTIC VALVED CONDUIT UNDERWENT A VALVE-IN-VALVE PROCEDURE AFTER AN IMPLANT DURATION OF 4 YEARS, 1 MONTH DUE TO SEVERE STENOSIS. THE PATIENT PRESENTED WITH HEART FAILURE, SOB, AND CARDIOGENIC SHOCK. THE PROCEDURE WAS PERFORMED WITH A 29MM 9755RSL TRANSCATHETER VALVE. THE PATIENT WAS DISCHARGED POD #8. PER MEDICAL RECORDS, THE PATIENT PRESENTED WITH CARDIOGENIC SHOCK IN THE SETTING OF NYHA CLASS IV HEART FAILURE AND NSTEMI. TAVR PROCEDURE WAS PERFORMED TO DISABLE THE 29MM VALVED CONDUIT AND IMPLANT A 29MM SUR. THE PATIENT WAS DISCHARGED POD #8. IT WAS NOTED THAT THE PATIENT HAS AN ESRD AND IS CURRENTLY ON HEMODIALYSIS.

  Patient problems: Cardiogenic Shock

  MAUDE report 24214539 ↗

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