INSPIRIS RESILIA AORTIC VALVERecalls & reported problems across all models
Edwards Lifesciences LLC · 6 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,305
- Deaths reported
- 5
- Injuries reported
- 1,291
- Recalls
- 0
We found 6 models of INSPIRIS RESILIA AORTIC VALVE by Edwards Lifesciences LLC in the FDA's device registry (GUDID). Together they are named in 1,305 adverse event reports in the FDA's MAUDE database, received between Feb 4, 2021 and Sep 30, 2026 — classified as 5 deaths, 1,291 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (727 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 INSPIRIS RESILIA AORTIC VALVE problems
Device problems
- Insufficient Device Problem Information727
- Device Stenosis196
- Adverse Event Without Identified Device or Use Problem169
- Gradient Increase115
- Fluid/Blood Leak112
- Calcified106
- Degraded79
- Patient Device Interaction Problem75
Patient problems
- Insufficient Information924
- Heart Failure/Congestive Heart Failure220
- Dyspnea200
- Endocarditis146
- Fatigue62
- No Clinical Signs, Symptoms or Conditions53
- Chest Pain29
- Thrombosis/Thrombus29
INSPIRIS RESILIA AORTIC VALVE models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue2 deaths404 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue385 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue1 death223 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue2 deaths158 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue73 reports
- INSPIRIS RESILIA AORTIC VALVE 11500AHeart-Valve, Non-Allograft Tissue62 reports
Recent INSPIRIS RESILIA AORTIC VALVE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50947063 ↗InjurySep 24, 2026Insufficient Device Problem Information
It was learned through Implant Patient Registry that a 25mm 11500A Inspiris Resilia aortic valve in aortic position was explanted and replaced with a 25mm 11060A Konect valved conduit after an implant duration of 7 years, 6 months. Reportedly, 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 50885630 ↗InjurySep 24, 2026Insufficient Device Problem Information
It was learned through Implant Patient Registry that a 25mm 11500A Inspiris Resilia aortic valve in aortic position was explanted after an implant duration of 1 year and 30 days. Redo AVR was completed with another 25mm 11500A aortic valve and patient was in recovery post-operatively.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 50885231 ↗InjurySep 22, 2026Insufficient Device Problem Information
It was learned through Implant Patient Registry that a patient with a 25mm 11500A aortic valve was explanted after an implant duration of 5 months due to unknown reasons. The explanted valve was replaced with a 23mm 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 50853778 ↗InjurySep 18, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50829480 ↗InjurySep 18, 2026Device Stenosis
It was reported and later learned that a patient with a 27mm 11500A Inspiris Resilia aortic valve in aortic position underwent a valve in valve procedure after an implant duration of 7 years, 4 months due to stenosis. TAVR was completed with a 26mm 9755RSL transcatheter valve.
Patient problems: Insufficient Information
MAUDE report 50812918 ↗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 12, 2026Calcified
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 50745174 ↗InjurySep 11, 2026Intravalvular regurgitation
Patient problems: Dyspnea
MAUDE report 50742174 ↗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 11, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50740224 ↗InjurySep 11, 2026Insufficient Device Problem Information
Patient problems: Insufficient Information
MAUDE report 50740012 ↗InjurySep 8, 2026Device Stenosis
Patient problems: Heart Failure/Congestive Heart Failure
MAUDE report 50678917 ↗
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
- 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
- EDWARDS COMMANDER DELIVERY SYSTEM4 models · 261 reports · 1 recall
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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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