CROWN PRTRecalls & reported problems across all models
Corcym Canada Corp · 5 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 98
- Deaths reported
- 10
- Injuries reported
- 87
- Recalls
- 0
We found 5 models of CROWN PRT by Corcym Canada Corp in the FDA's device registry (GUDID). Together they are named in 98 adverse event reports in the FDA's MAUDE database, received between Jul 14, 2016 and Jan 15, 2026 — classified as 10 deaths, 87 injuries, 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (26 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 CROWN PRT problems
Device problems
- Insufficient Device Problem Information26
- Calcified18
- Degraded13
- Incomplete Coaptation12
- Adverse Event Without Identified Device or Use Problem10
- Gradient Increase9
- Difficult to Open or Close6
- Material Deformation6
Patient problems
- Aortic Valve Stenosis24
- Aortic Insufficiency17
- Aortic Valve Insufficiency/ Regurgitation16
- No Information14
- Endocarditis13
- Aortic Regurgitation11
- Death8
- Calcium Deposits/Calcification5
CROWN PRT models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- CROWN PRT CNA21heart-valve, non-allograft tissue3 deaths31 reports
- CROWN PRT CNA23heart-valve, non-allograft tissue1 death26 reports
- CROWN PRT CNA19heart-valve, non-allograft tissue4 deaths25 reports
- CROWN PRT CNA25heart-valve, non-allograft tissue2 deaths14 reports
- CROWN PRT CNA27heart-valve, non-allograft tissue2 reports
Recent CROWN PRT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 15, 2026Degraded
THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A CROWN VALVE IN SIZE 23 WHICH OCCURRED ON (B)(6) 2025. THE FOLLOWING PROVIDES A COMPREHENSIVE SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. AFTER REVIEWING THE CASE, IT WAS CONFIRMED THAT THE CROWN 23 VALVE WAS NOT WORKING PROPERLY, AND THE DECISION WAS MADE TO REPLACE IT. THE PATIENT¿S HEIGHT AND WEIGHT AT THE TIME OF THE ORIGINAL IMPLANT ARE UNKNOWN. THE CROWN 23 VALVE HAD BEEN IMPLANTED IN (B)(6) 2023 WITH A GOOD IMMEDIATE POSTOPERATIVE OUTCOME AND AN INITIALLY FAVORABLE EVOLUTION. HOWEVER, DURING SUBSEQUENT FOLLOW-UP ECHOCARDIOGRAMS, A PROGRESSIVE INCREASE IN TRANSVALVULAR VELOCITIES WAS OBSERVED. WHAT BEGAN AS MILD STENOSIS GRADUALLY WORSENED OVER TIME. ON (B)(6) 2025, THE PATIENT PRESENTED TO THE OUTPATIENT CLINIC WITH DYSPNEA THAT HAD PROGRESSED OVER THE PREVIOUS 15 DAYS. THE PATIENT WAS EVALUATED BY THE CARDIOLOGY TEAM, AND HOSPITALIZATION WAS INDICATED. ECHOCARDIOGRAPHY REVEALED SEVERELY IMPAIRED LEAFLET MOBILITY, IMPROPER VALVE OPENING, MILD REGURGITATION, AND SEVERE STENOSIS WITH VELOCITIES EXCEEDING 5 M/S. ANTICOAGULATION WITH HEPARIN FOLLOWED BY WARFARIN WAS INITIATED TO RULE OUT THROMBOTIC OB
Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased
MAUDE report 24080176 ↗InjuryJul 1, 2025Calcified; Calcified
THE MANUFACTURER WAS NOTIFIED OF AN EARLY EXPLANT INVOLVING A CROWN PRT BIOLOGICAL AORTIC HEART VALVE (UNKNOWN SIZE AND SERIAL #) WHICH WAS IMPLANTED IN A JUVENILE PATIENT. AS REPORTED, THE PROSTHESIS WAS EXPLANTED AFTER ABOUT 12 MONTHS DUE TO AORTIC STENOSIS . ACCORDING TO THE INFORMATION RECEIVED, THE VALVE WAS FULLY CALCIFIED. THIS PROSTHESIS WAS REPLACED WITH A CARBOMEDICS STANDARD MECHANICAL AORTIC VALVE SIZE 21. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME AND THE EXPLANTED VALVE WILL BE RETURNED FOR INVESTIGATION.
Patient problems: Aortic Valve Stenosis
MAUDE report 22370559 ↗InjuryMar 19, 2025Degraded; Degraded
THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT OF A CROWN BIOPROSTHESIS CNA23 OCCURRED ON (B)(6) 2024 DUE TO AORTIC STENOSIS. ADDITIONAL INDICATIONS FOR THE RE-DO PROCEDURE WERE ASCENDING AORTA AS WELL AS AORTIC ANNULUS DILATION. AS REPORTED, THE VALVE HAD BEEN IMPLANTED ON (B)(6) 2020 THROUGH MINISTERNOTOMY DUE TO SEVERE AORTIC STENOSIS. AT THE TIME OF INITIAL SURGERY THE HEART WAS FOUND ENLARGED IN ALL FOUR CHAMBERS AND THE AORTIC NATIVE VALVE APPEARED SEVERELY COMPROMISED BY CALCIFICATION. THE ASCENDING AORTA WAS MEASURED AT 41 MM, SO IT WAS DECIDED NOT TO REPLACE IT. BASED ON THE INFORMATION RECEIVED, AT THE TIME OF THE RE-DO SURGERY THE HEART WAS FOUND ENLARGED AND THE ASCENDING AORTA SEVERELY DILATED. THE AORTA WAS COMPLETELY SECTIONED, AND SEVERE AORTIC ANNULUS DILATION WAS OBSERVED. A BIOLOGICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER WAS IMPLANTED (ST JUDE FREESTYLE SIZE 23) IN COMBINATION WITH DACRON TUBE SIZE 26 AND SIZE 28 WITHOUT REPORTED COMPLICATIONS.
Patient problems: Aortic Valve Stenosis; Transvalvular Pressure Gradient Increased
MAUDE report 21641349 ↗InjuryMar 19, 2025Calcified; Calcified
THE MANUFACTURER WAS INFORMED OF AN EARLY EXPLANT INVOLVING A CROWN VALVE CNA23 BIOPROSTHESIS. THE DEVICE HAD BEEN IMPLANTED ON (B)(6) 2022 IN A PATIENT DIAGNOSED WITH SEVERE AORTIC STENOSIS AND INSUFFICIENCY, WITH A BICUSPID NATIVE VALVE, ALONG WITH MODERATE MITRAL AND TRICUSPID INSUFFICIENCY. THE PATIENT HAD A MEDICAL HISTORY OF HEART FAILURE AND CHRONIC RENAL DISEASE. AS REPORTED, MITRAL VALVE REPAIR WITH A MEMO 3D RECHORD SIZE 34 AND IMPLANTATION OF 2 ARTIFICIAL CHORDAE TENDINEAE, AS WELL AS TRICUSPID ANNULOPLASTY USING THE DE VEGA TECHNIQUE WERE PERFORMED AS CONCOMITANT PROCEDURES. REPORTEDLY THE SURGERY WAS COMPLETED WITHOUT COMPLICATIONS. BASED ON THE INFORMATION RECEIVED, ON 12 FEBRUARY 2025 THE CROWN PROSTHESIS WAS EXPLANTED DUE TO PROSTHETIC DYSFUNCTION AND REPLACED WITH A CARBOMEDICS TOP HAT MECHANICAL VALVE S5-023. DURING THE SAME SURGERY, A MITRAL VALVE REPLACEMENT WITH A MECHANICAL PROSTHESIS FROM A DIFFERENT MANUFACTURER (MEDTRONIC SIZE 27) WAS PERFORMED DUE TO RECURRENT INSUFFICIENCY, DESPITE THE MEMO 3D RING FUNCTIONING PROPERLY. ACCORDING TO THE INFORMATION RECEIVED, THE CROWN PROSTHESIS APPEARED SEVERELY CALCIFIED UPON REOPERATION. THE SURGERY WAS COMPLETED WITHO
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 21640828 ↗InjurySep 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information
MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH COMPETITOR'S PATIENT TRACKING. BASED ON THE INFORMATION RECEIVED, THE CROWN PRT VALVE CNA19 WAS IMPLANTED IN A PATIENT ON (B)(6) 2022. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 AND REPLACED WITH INSPIRIS VALVE 19MM. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20161232 ↗DeathJul 23, 2024Degraded; Gradient Increase; Insufficient Device Problem Information; Degraded; Gradient Increase; Insufficient Device Problem Information
THE MANUFACTURER WAS INFORMED OF A PATIENT¿S DEATH OCCURRED DURING A RE-DO AVR SURGERY PERFORMED TO EXPLANT A CROWN BIOPROSTHESIS SIZE 25 DUE TO AN INFECTION WHICH COULD NOT BE SUCCESSFULLY TREATED WITH ANTIBIOTIC THERAPY. REPORTEDLY, PATIENT HAD 3 POSITIVE BLOOD CULTURES WITH STREPTOCOCCUS EPIDERMIDIS. DATE WHEN INFECTION WAS DIAGNOSED IS NOT KNOWN TO THE MANUFACTURER AT THIS TIME. AS REPORTED, THE PATIENT HAD NO PREVIOUS HISTORY OF INFECTIVE ENDOCARDITIS. THE CROWN PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2024 AND AN AORTIC PATCH HAD ALSO BEEN INSERTED FOR ROOT WIDENING AT THE TIME OF INITIAL IMPLANT, WITH A TOTAL BYPASS TIME OF 243 MINS. ACCORDING TO THE INFORMATION RECEIVED, AFTER THE INITIAL SURGERY THE PATIENT WAS READMITTED TO OR FOR CARDIAC TAMPONADE REPAIR AND VENTRICLE PACING WIRE INSERTION. THE CROWN VALVE WAS REPORTED TO BE FULLY FUNCTIONAL, WITH NORMAL GRADIENTS AND NO REGURGITATION, AFTER THIS SECOND SURGICAL PROCEDURE. LENGTH OF STAY IS NOT KNOWN TO THE MANUFACTURER AT THIS TIME. BASED ON THE INFORMATION RECEIVED, AT THE TIME OF RE-DO AVR SURGERY THE PATIENT PRESENTED WITH A HEART BLOCK ON A BACKGROUND OF SEVERE AORTIC STENOSIS. AS REPORTED, AFTER REMOVAL OF THE CROWN
Patient problems: Bacterial Infection; Endocarditis
MAUDE report 19804027 ↗InjuryDec 29, 2023Degraded; Material Deformation; Degraded; Material Deformation
THE MANUFACTURER WAS INFORMED THAT A CROWN CNA 19 VALVE WAS IMPLANTED IN A PATIENT ABOUT 4 MONTHS AGO IN (B)(6) 2023. SINCE SVD AND PVL WERE NOTED, THE VALVE IS PLANNED TO BE EXPLANTED IN (B)(6) 2023. REPORTEDLY, THE DETAILS WILL BE PROVIDED AFTER RE-OPERATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 18422161 ↗InjuryDec 14, 2023Calcified; Degraded; Calcified; Degraded
THE MANUFACTURER WAS INFORMED THAT IN MARCH 2020, A CROWN VALVE (UNKNOWN SIZE) WAS IMPLANTED IN THE PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2023 SINCE AS AND AR WERE NOTED AT THE FOLLOW-UP EXAMINATION (I.E., AVA: 0.72, VMAX: OVER 5M/SEC, PG:71MMHG), AND THE LEAFLETS OF THE VALVE WAS NOT WORKING CORRECTLY. INSPIRIS 21MM WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 18330585 ↗InjuryDec 1, 2023Degraded; Degraded
A CROWN VALVE SIZE 19 WAS IMPLANTED IN 2018. REPORTEDLY, ON (B)(6) 2023, THE VALVE WAS EXPLANTED SINCE AORTIC STENOSIS AND AORTIC REGURGITATION DUE TO SVD WERE NOTED. BASED ON THE INFORMATION AVAILABLE, REGENT 19 WAS IMPLANTED INSTEAD AS THE REPLACEMENT. THERE WAS NO IMPACT ON THE PATIENT AND OUTCOME WAS GOOD. THE MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis
MAUDE report 18250721 ↗InjuryOct 24, 2023Calcified; Calcified
THE MANUFACTURER WAS INFORMED THAT ON (B)(6) 2018, A CROWN PRT HEART VALVE SIZE 21 WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED AND REPLACED WITH PERCEVAL S VALVE SIZE 21 ON (B)(6) 2023 SINCE SVD WAS NOTED. BASED ON THE FURTHER INFORMATION RECEIVED, THERE WAS OVERGROWTH OF PANNUS AND CALCIFICATION ON THE VALVE. AS SUCH, THE VALVE WAS NOT FUNCTIONING PROPERLY. AS REPORTED, OUTCOME WAS GOOD. NO FURTHER INFORMATION WILL BE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 17997230 ↗InjuryJul 11, 2022Leak/Splash; Leak/Splash
ON (B)(6) 2022, INSPIRIS VALVE WAS ATTEMPTED TO BE IMPLANTED. HOWEVER, THE DEVICE CROWN PRT PERICARDIAL HEART VALVE CNA19 WAS SELECTED AND IMPLANTED BECAUSE THE INSPIRIS SIZER 19MM WAS TIGHT. AFTER DE-CLAMP, ECHO SHOWED REGURGITATION. ECHO COULD NOT DETERMINE WHETHER IT WAS PARAVALVULAR LEAKAGE OR TRANSVALVULAR LEAKAGE. IT SEEMED TO BE PVL OR TVL CLOSER TO THE STENT POST. SINCE THE LEAKAGE WAS MILD, THE DEVICE WAS EXPLANTED AND THE INSPIRIS 19MM WAS IMPLANTED INSTEAD FINALLY. AFTER DE-CLAMP, ECHO SHOWED NO LEAKAGE AND THE OPERATION WAS COMPLETED WITHOUT ANY PROBLEM. THE CONCOMITANT PROCEDURE WAS AN ASCENDING AORTA REPLACEMENT. OPERATION TIME WAS ADDED 60 MINUTES BECAUSE OF THIS EVENT. THE PATIENT REMAINED STABLE THROUGHOUT DELAY IN PROCEDURE. THE PATIENT OUTCOME IS NO PROBLEM, THE PATIENT WEANED UNEVENTFULLY AND THERE WAS NO PATIENT IMPACT. AS REPORTED, THE PATIENT¿S ANNULUS DIMENSIONS MEASURED PRE-OPERATIVELY WAS APPROXIMATELY 19MM. THE CROWN 19 WAS IMPLANTED SUPRA ANNULARLY. NO DECALCIFICATION WAS PERFORMED AFTER THE CROWN VALVE EXPLANT AND THE INSPIRIS VALVE IMPLANT.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 14981328 ↗InjuryMay 16, 2022Calcified; Calcified
ON 7 APRIL 2022, A CROWN VALVE CNA21 WHICH WAS IMPLANTED ON (B)(6) 2017 WAS EXPLANTED DUE TO SEVERE CALCIFICATION AND INSPIRIS 21MM VALVE WAS IMPLANTED INSTEAD. BASED ON THE ADDITIONAL INFORMATION RECEIVED, AFTER IMPLANTING THE DEVICE, A SLIGHT PARAVALVULAR LEAK WAS OBSERVED. IN THE FOLLOW UPS, IT WAS NOTED THAT THE PRESSURE GRADIENT AND PEAK AORTIC JET VELOCITY IS INCREASING AND AORTIC VALVE AREA IS DECREASING EACH YEAR. PATIENT IS UNDER DOAC (EDOXABAN TOSILATE HYDRATE) MEDICATION. NO ILLNESS FOR THE PATIENT HAS BEEN REPORTED. BASED ON THE INFORMATION RECEIVED, PATIENT IS DOING WELL. IT WAS DECIDED TO CONDUCT A PATHOLOGICAL EXAMINATION AT THE HOSPITAL. THEREFORE, THE DEVICE WILL NOT BE RETURNED.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 14410135 ↗InjuryApr 4, 2022Degraded; Degraded
THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT: THE PATIENT WHO HAD CROWN VALVE IMPLANTATION SURGERY WITH MIDLINE INCISION SIMULTANEOUS WITH CABG (LITA-LAD, AO-SVG-RCA) ON (B)(6) 2016, UNDERWENT THE EMERGENCY SURGERY DUE TO SEVERE AORTIC REGURGITATION CAUSED BY SVD ON (B)(6) 2022. THE VALVE WAS EXPLANTED AND PVS21 WAS IMPLANTED INSTEAD. ECHO PREFORMED AFTER RE-AVR SHOWED NO LEAKAGE AND NO MALFUNCTION OF THE PERCEVAL VALVE.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 14003924 ↗InjuryMar 8, 2022Incomplete Coaptation; Incomplete Coaptation
ON (B)(6) 2022, THE CNA19 CROWN VALVE WAS IMPLANTED SUPRA ANNULAR BY MIDLINE INCISION. THE CONCOMITANT PROCEDURE WAS TRICUSPID ANNULOPLASTY. AFTER DE-CLAMPING, THE DEVICE FUNCTIONALITY WAS CHECKED BY THE ECHO AND CENTRAL LEAKAGE WAS DETECTED. THEY RE-CLAMPED AND PERFORMED ADDITIONAL STITCHES USING THE SUTURE WITH FELT, BUT IT WAS NOT SUCCESSFUL. ULTIMATELY, THE DEVICE WAS EXPLANTED AND INSPIRIS 19 MM WAS IMPLANTED INSTEAD WITH NO ISSUE. BASED ON THE INFORMATION RECEIVED, THERE WAS NO IMPACT ON THE PATIENT.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 13690870 ↗InjuryJan 11, 2022Incomplete Coaptation; Incomplete Coaptation
ON (B)(6) 2021 A CROWN PRT VALVE WAS IMPLANTED AND EXPLANTED ON THE SAME DAY DUE TO THE REGURGITATION. BASED ON THE REPORT WRITTEN BY THE SURGEON, POST IMPLANTATION OF THE VALVE, ONE OF THE VALVE LEAFLET TISSUE APPEARED A BIT TOUGHER THAN THE OTHER TWO LEAFLETS. AFTER THE VALVE REPLACEMENT AND COMING OFF OF CARDIOPULMONARY BYPASS, THE TEE ON TABLE SHOWED A CENTRAL JET MODERATE TO SEVER AORTIC PROSTHESIS REGURGITATION AND COAPTATION FAILURE. SURGEON RE-OPENED THE AORTA AND FOUND THAT NCC LEAFLET WAS STRETCHED BY THE TWO COMMISSURES AND IT WAS NOT COAPTING AT THE SAME LEVEL AS THE OTHER TWO.
Patient problems: Aortic Valve Insufficiency/ Regurgitation
MAUDE report 13231589 ↗
Other Corcym Canada Corp products
All Corcym Canada Corp devices →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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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