PERCEVALRecalls & reported problems across all models

We found 4 models of PERCEVAL by Corcym Canada Corp in the FDA's device registry (GUDID). Together they are named in 850 adverse event reports in the FDA's MAUDE database, received between Jul 22, 2016 and Apr 16, 2026 — classified as 65 deaths, 765 injuries, 18 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (232 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 PERCEVAL problems

PERCEVAL models

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

• PERCEVAL PVS23

  heart-valve, non-allograft tissue
  26 deaths337 reports
• PERCEVAL PVS21

  heart-valve, non-allograft tissue
  15 deaths195 reports
• PERCEVAL PVS25

  heart-valve, non-allograft tissue
  13 deaths192 reports
• PERCEVAL PVS27

  heart-valve, non-allograft tissue
  11 deaths126 reports

Recent PERCEVAL adverse event reports

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

• InjuryApr 16, 2026Material Split, Cut or Torn

  THE MANUFACTURER WAS NOTIFIED OF AN ENDOCARDITIS EVENT INVOLVING A PERCEVAL VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE. A PERCEVAL VALVE PVS25/L WAS IMPLANTED IN A PATIENT ON (B)(6) 2021 THROUGH MICS APPROACH, TYPE 0. ONE OF THE VALVE LEAFLETS WAS TORN AND THE SURGEON INDICATED THAT IT IS DUE TO ENDOCARDITIS. THE VALVE WAS EVENTUALLY EXPLANTED ON (B)(6) 2026. NO OTHER FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Endocarditis

  MAUDE report 24904074 ↗
• InjuryJan 18, 2026Calcified

  MANUFACTURER WAS INFORMED THAT A PATIENT WHO HAD A PERCEVAL VALVE SIZE S IMPLANTED ON (B)(6) 2021, NOW HAS GENERATED SVD. ACCORDING TO THE ORIGINAL OPERATIVE RECORD, ANNULUS DIAMETER MEASURED INTRAOPERATIVELY WAS 22 MM; IMPLANTED AS USUAL, WITH A NOTE THAT THE RCC OF THE PROSTHETIC VALVE APPEARED SLIGHTLY FOLDED. POSTOPERATIVE TTE SHOWED NO PARAVALVULAR LEAKAGE AND TRIVIAL TRANSVALVULAR LEAKAGE. REPORTEDLY, PATIENT WAS HOSPITALIZED FOR HEART FAILURE; MARKED ASCITES DUE TO CONCOMITANT LIVER CIRRHOSIS, BUT SYMPTOMS IMPROVED AFTER PARACENTESIS AND WAS DISCHARGED. CT REVEALED CALCIFICATION OF ALL THREE CUSPS; DIAGNOSED AS SVD RATHER THAN PROSTHETIC VALVE THROMBOSIS. PATIENT'S MEDICATIONS ARE REPORTED AS: FUROSEMIDE 20 MG, BAYASPIRIN 100 MG, TAKECAB 10 MG, FEBUXOSTAT 10 MG, BISOPROLOL FUMARATE 2.5 MG, LOFLAZEPATE ETHYL 1 MG, URSODEOXYCHOLIC ACID 300 MG, AMITIZA CAPSULE 12 G, DAYVIGO 2.5 MG, TOLVAPTAN 11.25 MG, SPIRONOLACTONE 25 MG, LIONA TABLET 500 MG, LIXIANA 15 MG.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24106756 ↗
• InjuryJul 17, 2025Degraded; Degraded

  A PATIENT WITH PRIOR AORTIC STENOSIS SIP SURGICAL AVR IN 2017 AT THE (B)(6) VA WITH A LARGE PERCEVAL PROSTHESIS· AND TAVR (EVOLUTE, UNKNOWN SIZE) IN (B)(6) 2019 AT (B)(6) FOR PROSTHETIC VALVE STENOSIS WITH A MILD-MODERATE PERIVALVULAR LEAK, STABLE MILD CARDIOMYOPATHY WITH NORMAL LV DIMENSIONS. BIOTRONIC DUAL CHAMBER PACEMAKER FOR COMPLETE HEART BLOCK AFTER TAVR, CAD WITH VERY RECENT ATHERECTOMY/PCI TO MID LAD, PAF IN NSR, IDDM, CIRRHOSIS, PRESBYCUSIS, AND OTHER MEDICAL ISSUES. PATIENT WAS EVALUATED INITIALLY FOR ANGINA/DYSPNEA S/P LAD ATHERECTOMY/PCI LAST WEEK AND MEDICAL OPTIMIZATION WHICH HAS BEEN SUCCESSFUL TO RESOLVE THE SYMPTOMS. PATIENT'S EF HAS BEEN MILDLY DEPRESSED/STABLE SINCE 2022 WITH NO LV DILATION, AND NO SIGN OF INFECTION OF THE VALVE COMPLEX. PATIENT IS ALSO NEWLY ANEMIC POSSIBLY FROM HOMOLYSIS ALONG WITH AMS WITH UNCLEAR CAUSE. THERE IS NO CURRENT INDICATION FOR REPEAT VALVULAR INTERVENTION, AND SURGERY CANNOT BE PERFORMED GIVEN THE RECENT CORONARY INTERVENTION AND THE NEED FOR DAPT. REPORTEDLY, PATIENT WAS EVALUATED A MONTH AGO BY CARDIOLOGY FOR CHEST PAIN, DYSPNEA, AND DIZZINESS. TTE SHOWED EF 45-50%, LVIDD 4.5/LVIPS 3.1, SEPTAL WALL MOTION FROM PACING, MOD-SEVERE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22536119 ↗
• InjuryJul 17, 2025Degraded; Degraded

  A PATIENT WITH PRIOR AORTIC STENOSIS SIP SURGICAL AVR IN 2017 AT THE TAMPA VA WITH A LARGE PERCEVAL PROSTHESIS· AND TAVR (EVOLUTE, UNKNOWN SIZE) IN (B)(6) 2019 AT (B)(6) FOR PROSTHETIC VALVE STENOSIS WITH A MILD-MODERATE PERIVALVULAR LEAK, STABLE MILD CARDIOMYOPATHY WITH NORMAL LV DIMENSIONS. BIOTRONIC DUAL CHAMBER PACEMAKER FOR COMPLETE HEART BLOCK AFTER TAVR, CAD WITH VERY RECENT ATHERECTOMY/PCI TO MID LAD, PAF IN NSR, IDDM, CIRRHOSIS, PRESBYCUSIS, AND OTHER MEDICAL ISSUES. PATIENT WAS EVALUATED INITIALLY FOR ANGINA/DYSPNEA S/P LAD ATHERECTOMY/PCI LAST WEEK AND MEDICAL OPTIMIZATION WHICH HAS BEEN SUCCESSFUL TO RESOLVE THE SYMPTOMS. PATIENT'S EF HAS BEEN MILDLY DEPRESSED/STABLE SINCE 2022 WITH NO LV DILATION, AND NO SIGN OF INFECTION OF THE VALVE COMPLEX. PATIENT IS ALSO NEWLY ANEMIC POSSIBLY FROM HOMOLYSIS ALONG WITH AMS WITH UNCLEAR CAUSE. THERE IS NO CURRENT INDICATION FOR REPEAT VALVULAR INTERVENTION, AND SURGERY CANNOT BE PERFORMED GIVEN THE RECENT CORONARY INTERVENTION AND THE NEED FOR DAPT. REPORTEDLY, PATIENT WAS EVALUATED A MONTH AGO BY CARDIOLOGY FOR CHEST PAIN, DYSPNEA, AND DIZZINESS. TTE SHOWED EF 45-50%, LVIDD 4.5/LVIPS 3.1, SEPTAL WALL MOTION FROM PACING, MOD-SEVERE

  Patient problems: Aortic Valve Stenosis

  MAUDE report 22536117 ↗
• InjuryJun 17, 2025Calcified; Calcified

  ON (B)(6) 2022, A PERCEVAL VALVE PVS23 WAS IMPLANTED IN A PATIENT. REPORTEDLY, THE VALVE WAS EXPLANTED ON (B)(6) 2025, DUE TO SVD (CALCIFICATION) AND THE VALVE WAS REPLACED WITH INSPRIS VALVE SIZE 23MM INSTEAD. BASED ON THE INFORMATION PROVIDED, PATIENT WAS ON DIALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22242886 ↗
• DeathMay 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE PVS21 WAS IMPLANTED ON (B)(6) 2019. REPORTEDLY, PATIENT PASSED AWAY ON (B)(6) 2024 DUE TO UNKNOWN REASON. PER MEDICAL JUDGMENT RECEIVED, HEPATOCELLULAR CARCINOMA, CHRONIC DIC, AND POOR NUTRITIONAL STATUS COULD BE POSSIBLE REASONS, BUT THE EXACT CAUSE CANNOT BE DETERMINED. MANUFACTURER WAS INFORMED THAT NO FURTHER INFORMATION WILL BE RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 21981427 ↗
• DeathMar 23, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  RECEIVED THE FOLLOWING INFORMATION FROM PATIENT TRACKING SYSTEM. A PERCEVAL VALVE PVS23 WAS IMPLANTED IN A PATIENT ON (B)(6) 2024. THE PATIENT PASSED AWAY AT UNKNOWN DATE DUE TO UNKNOWN REASON. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21673668 ↗
• InjuryJan 21, 2025Perivalvular Leak; Perivalvular Leak

  MANUFACTURER WAS INFORMED THAT THE VALVE WAS IMPLANTED ON (B)(6) 2024. REPORTEDLY, MODERATE PVL WAS NOTED AFTER THE SURGERY, BUT THE SURGERY WAS COMPLETED. AT THE FOLLOW UP EXAMINATION, IT WAS NOTED THAT PVL GOT WORSE, AND THE VALVE WAS ULTIMATELY EXPLANTED ON (B)(6) 2024 AND REPLACED WITH EPIC 19 VALVE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 21194612 ↗
• InjuryJan 9, 2025Degraded; Degraded

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE PVS21 WAS IMPLANTED ON (B)(6) 2022. REPORTEDLY, SINCE SVD WAS FOUND, THE VALVE WAS EXPLANTED AND REPLACED BY AVALUS 19MM ON (B)(6) 2024. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 21108818 ↗
• InjuryJan 7, 2025Calcified; Degraded; Calcified; Degraded

  THE MANUFACTURER WAS NOTIFIED OF AN EARLY EXPLANT OF A PERCIVAL S VALVE PVS25 THAT OCCURRED ON (B)(6) 2024. THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2020, VIA THE RAT APPROACH DUE TO SEVERE AORTIC VALVE STENOSIS AND INSUFFICIENCY. THE PATIENT HAD A HISTORY OF CORONARY ARTERY DISEASE AND TYPE 2 DIABETES MELLITUS, DIAGNOSED AT THE TIME OF THE PERCIVAL VALVE IMPLANT. THE PATIENT HAD SUFFERED AN INFERIOR MYOCARDIAL INFARCTION IN (B)(6) 2010, TREATED WITH PCI AND A BARE METAL STENT IN THE RIGHT CORONARY ARTERY (RCA), WITH VENTRICULAR FIBRILLATION AS A COMPLICATION. IN (B)(6) 2015, A 90% OCCLUSION OF THE RCA WAS TREATED AGAIN WITH PCI (BMS 4.0/22). IN (B)(6) 2020, CORONARY ANGIOGRAPHY (CAG) SHOWED A MID-LAD (50-69%) LESION, GROWTH IN THE STENT-RCA BUT SUFFICIENTLY PATENT, NO AORTIC INSUFFICIENCY, NO CALCIFICATION IN THE ASCENDING AORTA, AND SLIGHT DILATION. IN (B)(6) 2023, A TRANSESOPHAGEAL ECHOCARDIOGRAM SHOWED MODERATE STENOSIS OF THE PERCIVAL VALVE, WITH AN AORTIC VALVE AREA OF 1.43 CM² AND SLIGHT PLAQUE FORMATION IN THE DESCENDING AORTA. IN (B)(6) 2024, A NON-ST ELEVATION MYOCARDIAL INFARCTION REQUIRED PCI ON THE RIGHT POSTERIOR LATERAL AND DISTAL RCA WITH THE APPLICATION OF TWO D

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Coronary obstruction/occlusion; Obstruction/Occlusion; Syncope/Fainting; Transvalvular Pressure Gradient Increased

  MAUDE report 21089090 ↗
• InjuryJan 2, 2025Perivalvular Leak; Deformation Due to Compressive Stress; Perivalvular Leak; Deformation Due to Compressive Stress

  THE MANUFACTURER WAS NOTIFIED OF A PERCEVAL S VALVE EXPLANT THAT OCCURRED ON THE FIRST POST-OPERATIVE DAY DUE TO A PARAVALVULAR LEAK (PVL) AND INCREASED GRADIENTS (40 MMHG). REPORTEDLY, THE PROSTHESIS WAS IMPLANTED DURING AN ISOLATED AVR SURGERY, WITH NO DIFFICULTIES ENCOUNTERED IN COLLAPSING AND POSITIONING THE DEVICE. ACCORDING TO THE INFORMATION RECEIVED, POST-DILATION OF THE INFLOW RING WAS PERFORMED AFTER THE COMPLETE DEPLOYMENT OF THE PROSTHESIS, AS PRESCRIBED BY THE IFU, AND NO COMPLICATIONS WERE EXPERIENCED DURING THE SURGERY. BASED ON THE INFORMATION RECEIVED, THE PATIENT'S NATIVE VALVE WAS TRICUSPID AND STENO-INSUFFICIENT, WITH PREDOMINANT AORTIC STENOSIS. ALTHOUGH THE ANNULUS GEOMETRY WAS NOT ABNORMAL, THERE WAS SOME DEGREE OF CALCIFICATION OF THE MITRAL ANNULUS. AS REPORTED, THE DAY AFTER SURGERY IT WAS DECIDED TO REINTERVENE ON THE PATIENT AND REPLACE THE PERCEVAL VALVE WITH A CONVENTIONAL BIOPROSTHESIS (CORCYM CROWN 21 MM) DUE TO THE PARAVALVULAR LEAK AND INCREASED PRESSURE GRADIENTS, WHICH LEFT THE PATIENT IN CRITICAL CONDITION. THE CORONARY ARTERIES WERE REPORTED TO BE PERMEABLE. ACCORDING TO THE MEDICAL JUDGEMENT RECEIVED, THE PVL WAS CAUSED BY A DEFORMATION OF THE

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Transvalvular Pressure Gradient Increased

  MAUDE report 21054964 ↗
• InjuryNov 7, 2024Degraded; Degraded

  THE MANUFACTURER WAS INFORMED THAT A TAVI WAS RECENTLY PERFORMED INSIDE A PERCEVAL S SIZE 25 PROSTHESIS IMPLANTED IN 2020. THE MANUFACTURER HAS FOLLOWED UP WITH THE IMPLANTING SURGEON TO RETRIEVE ADDITIONAL DETAILS ON THE EVENT AND THE DEVICE INVOLVED BUT HAS BEEN INFORMED THAT NO FURTHER INFORMATION WILL BE DISCLOSED.

  Patient problems: Insufficient Information

  MAUDE report 20636426 ↗
• InjuryNov 1, 2024Degraded; Degraded

  MANUFACTURER WAS INFORMED THAT A PERCEVAL VALVE SIZE 23 WHICH WAS IMPLANTED ON (B)(6) 2019, WAS EXPLANTED ON AN UNKNOWN DATE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 20593645 ↗
• InjuryOct 25, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT REGISTRATION FORM, ON (B)(6) 2021, PVS27 WAS EXPLANTED INTRA-OPERATIVELY. REPORTEDLY, PATIENT IS NOW DECEASED. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE MALFUNCTION NOR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20530403 ↗
• InjuryOct 23, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER WAS INFORMED OF THE EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON PATIENT REGISTRATION FORM, ON (B)(6) 2021, PVS27 WAS EXPLANTED INTRA-OPERATIVELY. REPORTEDLY, PATIENT IS NOW DECEASED. NO FURTHER INFORMATION HAS BEEN RECEIVED FROM THE SITE ABOUT ANY DEVICE MALFUNCTION NOR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 20518298 ↗

Other Corcym Canada Corp products

• MITROFLOW10 models · 227 reports
• PERCEVAL PLUS4 models · 149 reports
• CROWN PRT5 models · 98 reports
• SOLO SMART4 models · 20 reports