PERCEVAL PVS23 (UDI 08022057014702)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 08022057014702), received between Jan 10, 2022 and Aug 13, 2026 — classified as 1 death, 8 injuries.

The most frequently reported specific device problem is “Collapse” (4 reports).

1 other recall cover devices cleared under the same FDA submission (P150011); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Collapse

  The manufacturer was notified of the intraoperative explant of a Perceval S size M valve. The following provides a comprehensive summary of all information currently available to the manufacturer. On (b)(6) 2026, an attempt was made to implant a Perceval S valve, size M (PVS23). However, stent infolding was observed during the procedure. Consequently, the valve was explanted and replaced with another Perceval valve of unknown size. No further information is available at this time.

  Patient problems: Insufficient Information

  MAUDE report 50233393 ↗
• DeathApr 3, 2026Insufficient Device Problem Information

  THE MANUFACTURER WAS NOTIFIED OF A DEATH EVENT INVOLVING A PATIENT IMPLANTED WITH A PERCEVAL S SUTURELESS AORTIC BIOPROSTHESIS ON (B)(6) 2021. ACCORDING TO THE NOTIFICATION RECEIVED, THE PATIENT PASSED AWAY FOLLOWING REPEATED SYNCOPE ATTRIBUTED TO AN EARLY DEGENERATION OF THE PERCEVAL PROSTHESIS. BASED ON THE PRELIMINARY ADDITIONAL INFORMATION RETRIEVED, IN 2021 THE PROSTHESIS¿ GRADIENT WAS 14 MMHG AND WAS UNCHANGED AT A FOLLOW UP PERFORMED IN (B)(6) 2025. AT THE LAST ECHOCARDIOGRAPHIC EVALUATION PERFORMED PRIOR TO THE PATIENT¿S DEATH, THE MEASURED GRADIENT WAS 50 MMHG. A CT SCAN WAS ALSO PERFORMED AT THAT TIME AND A SUSPICION OF THROMBOSIS OF THE RIGHT CORONARY ARTERY WAS DESCRIBED. ACCORDING TO THE REPORTS RECEIVED, THE PERCEVAL PROSTHESIS HAD BEEN IMPLANTED IN NON-ANATOMICAL POSITION VIA MEDIAN STERNOTOMY WITHOUT COMPLICATIONS. THE PATIENT HAD A HEAVILY CALCIFIED TRICUSPID NATIVE VALVE, WITH A HIGHLY CALCIFIED ANNULUS. MITRAL DECALCIFICATION VALVULOPLASTY WAS PERFORMED AS CONCOMITANT PROCEDURE. THE PATIENT HAD A HISTORY OF BREAST CANCER, WAS UNDER MONITORING FOR A THYROID NODULE AT THE TIME OF PERCEVAL VALVE IMPLANT AND HAD THE FOLLOWING CARDIOVASCULAR RISK FACTORS: TYPE 2 DYAB

  Patient problems: Syncope/Fainting; Transvalvular Pressure Gradient Increased

  MAUDE report 24782127 ↗
• InjuryDec 19, 2025Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED OF THE EARLY EXPLANT OF A PERCEVAL S VALVE IN SIZE M PVS23. THE PROSTHESIS HAD REPORTEDLY BEEN IMPLANTED ON (B)(6) 2022, IN THE AORTIC POSITION. ACCORDING TO THE INFORMATION PROVIDED, THE VALVE LATER DEVELOPED STENOSIS WITH A SUSPECTED ENDOCARDITIS, LEADING TO ITS REMOVAL ON (B)(6) 2025. IT WAS SUBSEQUENTLY REPLACED WITH AN AVALUS NO. 21 BIOLOGICAL AORTIC VALVE. FURTHER DETAILS FROM THE SITE INDICATED THAT THE PERCEVAL VALVE FUNCTIONED PROPERLY FROM IMPLANTATION UNTIL 2025, WHEN THE PATIENT BEGAN EXPERIENCING DISCOMFORT. ADDITIONAL INFORMATION CONFIRMED THAT THERE WERE NO POSITIONING DIFFICULTIES DURING THE 2022 IMPLANTATION, NOR ANY ISSUES RELATED TO MALPOSITION OR INCORRECT SIZING. THE NATIVE VALVE WAS REPORTEDLY BICUSPID.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23849323 ↗
• InjuryNov 13, 2025Degraded; Degraded

  THE MANUFACTURER WAS NOTIFIED OF THE EXPLANTATION OF A PERCEVAL S AORTIC HEART VALVE SIZE 23, PVS23. REPORTEDLY, THE PROSTHESIS HAD BEEN IMPLANTED ON (B)(6) 2021. RECENT TRANSTHORACIC AND TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) CONFIRMED SEVERE BIOPROSTHETIC VALVE STENOSIS DUE TO EARLY DEGENERATION, WITH A MEAN GRADIENT OF 60 MMHG. THE EVALUATION REVEALED VERY SEVERE AORTIC STENOSIS, WITH A MEAN TRANSVALVULAR GRADIENT OF 44 MMHG AND AN AORTIC VALVE AREA OF 0.56 CM² (INDEXED AT 0.27 CM²/M²). THE EARLY DEGENERATION OF THE PROSTHESIS LED TO TWO EPISODES OF SYNCOPE. CONSEQUENTLY, THE PERCEVAL VALVE WAS EXPLANTED AND REPLACED WITH A 21 MM SAINT JUDE VALVE ON (B)(6) 2025. ACCORDING TO THE INFORMATION RECEIVED, THE PATIENT'S RISK FACTORS INCLUDE DIABETES, WITH A HISTORY OF HOSPITALIZATION IN FEBRUARY 2021 FOR DIABETIC HYPERGLYCEMIC DECOMPENSATION ACCOMPANIED BY MALAISE. OBESITY HAS BEEN REPORTED AS AN ADDITIONAL MEDICAL CONDITION.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 23543807 ↗
• InjuryJul 26, 2023Collapse; Gradient Increase; Collapse; Gradient Increase

  THE MANUFACTURER WAS MADE AWARE THROUGH A PUBLICATION THAT A PATIENT EXPERIENCED AN EARLY PERCEVAL VALVE EXPLANT DUE TO STENT INFOLDING. PREOPERATIVE TRANSTHORACIC ECHOCARDIOGRAPHY (TTE) DEMONSTRATED AN AORTIC VALVE AREA (AVA) OF 0.6 CM2 WITHOUT REGURGITATION, AND A PRESERVED LEFT VENTRICULAR FUNCTION. PREOPERATIVE COMPUTED TOMOGRAPHY (CT) REVEALED ROOT CALCIFICATION AND THE ANNULAR DIAMETER WAS ASSESSED TO BE 22 MM. A PERCEVAL S SIZE M WAS SELECTED AND IMPLANTED VIA AN UPPER HEMISTERNOTOMY ON (B)(4) 2013. REPORTEDLY, ACCURATE POSITIONING WAS CONFIRMED VISUALLY BEFORE AND AFTER DEPLOYMENT. INTRAOPERATIVE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) DEMONSTRATED A REGULAR POSITION AND NO PARAVALVULAR LEAK (PVL). POSTOPERATIVE COURSE WAS UNEVENTFUL AND PATIENT WAS DISCHARGED HOME ON POSTOPERATIVE DAY (POD) 8. ROUTINE TTE ON POD 27 SHOWED INFOLDING OF THE BIOPROSTHESIS, ELEVATED TRANSPROSTHETIC GRADIENTS OF 21/31 MMHG (MEAN/PEAK), AND MILD PVL. CT CONFIRMED DEFORMATION OF THE PROSTHESIS ANNULUS AND AN IMPRESSION OF THE STENT FRAME BETWEEN THE RIGHT AND LEFT CORONARY SINUSES. AS THIS WAS NOT ACCOMPANIED BY CLINICAL SYMPTOMS, THE PATIENT WAS CLOSELY FOLLOWED, UNDERGOING CORONARY ANGIOGRAPHY T

  Patient problems: Dyspnea; Heart Failure/Congestive Heart Failure; Vertigo

  MAUDE report 17396055 ↗
• InjurySep 9, 2022Perivalvular Leak; Perivalvular Leak

  THE MANUFACTURER WAS INFORMED OF A PERIVALVULAR LEAK AFTER IMPLANT OF PERCEVAL SUTURELESS AORTIC HEART VALVE, PVS23/SIZE M. THE VALVE WAS IMPLANTED ON (B)(6) 2021. AS REPORTED, SURGEONS WERE PLANNING TO IMPROVE PARAVALVULAR LEAK BY INTERVENTIONAL TREATMENT, SUCH AS PLACE AN OCCLUDER OR DILATION AGAIN WITH A BALLOON. BASED ON THE INFORMATION RECEIVED, SEVERE PARAVALVULAR LEAK APPEARED BUT THE TIME IS UNKNOWN. REPORTEDLY, THE VALVE WAS EXPLANTED, AND MAGNA EASE VALVE WAS IMPLANTED IN THE PATIENT AS A REPLACEMENT. THE EXACT EXPLANT DATE IS UNKNOWN. BASED ON THE MEDICAL JUDGMENT RECEIVED, THE VALVE WAS BICUSPID TYPE 0. BASED ON THE INFORMATION RECEIVED, SURGEONS DON¿T THINK THAT THIS WAS A PRODUCT ISSUE. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 15388473 ↗
• InjuryFeb 11, 2022Incomplete Coaptation; Difficult to Open or Close; Incomplete Coaptation; Difficult to Open or Close

  ON (B)(6) 2022, A PERCEVAL VALVE PVS23 /M WAS ATTEMPTED TO BE IMPLANTED. AFTER IMPLANTATION, TEE SHOWED ONE LEAFLET WITH ABNORMAL BEHAVIOR AND UNABLE TO CLOSE TIGHTLY. HENCE, THE SURGEON EXPLANTED THIS VALVE AND IMPLANTED A NEW ONE. THE SURGEON SIZED AGAIN AND CONFIRMED SIZE 23 /M WAS THE RIGHT CHOICE. AFTER THE NEW VALVE IMPLANT, THE PATIENT WAS FINE AND WITHOUT PERIVALVULAR LEAK (PVL).

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13515256 ↗
• InjuryJan 10, 2022Collapse; Perivalvular Leak; Collapse; Perivalvular Leak

  ON (B)(6) 2021, THE PERCEVAL VALVE S MODEL PVS23 WAS ATTEMPTED TO BE IMPLANTED. ACCORDING TO THE INFORMATION RECEIVED FROM THE SITE, THE PATIENT HAD A SEVER CALCIFICATION IN THE AORTIC VALVE WITH THE SMALL LUMEN OF ANNULUS, WHICH MADE THE DECALCIFICATION PROCESS COMPLICATED. THERE WERE NO COLLAPSING OR IMPLANTATION ISSUES DURING THE PROCEDURE. BALLOONING WAS STANDARD AND NORMAL. THE POSITION OF THE VALVE LOOKED CORRECT BY THE VISUAL CHECK. ALTHOUGH THE BLOOD FLOW WAS GOOD, ECHOCARDIOGRAM INDICATED GRADE II AND III PARAVALVULAR LEAK AT THE NON-CORONARY PART OF THE VALVE. BY FURTHER INVESTIGATION, A NOT COMPLETELY UNFOLDED VALVE IN THE NON-CORONARY SIDE WAS DETECTED. THE VALVE WAS REMOVED AND IMPLANTED BACK AGAIN. IN THE SECOND ATTEMPT THE BALLOONING TOOK PLACE WITH THE PRESSURE OF 5ATM FOR 30 SECONDS. THE SAME UNFOLDING ISSUE IN THE SAME SPOT OCCURRED. AT THE END, THE DECISION OF REMOVING THE VALVE HAS BEEN MADE. THE DOCTOR ENLARGED THE AORTIC ROOT WITH THE DACRON-PATCH, RESIZED THE ANNULUS AND DECIDED TO IMPLANT THE MAGNA EASE AORTIC VALVE 21MM. ACCORDING TO THE INFORMATION RECEIVED THE PATIENT WAS STABLE DURING THE SURGERY, AND NO ADVERSE IMPACT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13213682 ↗
• InjuryJan 10, 2022Collapse; Perivalvular Leak; Collapse; Perivalvular Leak

  ON (B)(6) 2021, THE PERCEVAL VALVE S MODEL PVS23 WAS ATTEMPTED TO BE IMPLANTED. ACCORDING TO THE INFORMATION RECEIVED FROM THE SITE, THE PATIENT HAD A SEVER CALCIFICATION IN THE AORTIC VALVE WITH THE SMALL LUMEN OF ANNULUS, WHICH MADE THE DECALCIFICATION PROCESS COMPLICATED. THERE WERE NO COLLAPSING OR IMPLANTATION ISSUES DURING THE PROCEDURE. BALLOONING WAS STANDARD AND NORMAL. THE POSITION OF THE VALVE LOOKED CORRECT BY THE VISUAL CHECK. ALTHOUGH THE BLOOD FLOW WAS GOOD, ECHOCARDIOGRAM INDICATED GRADE II AND III PARAVALVULAR LEAK AT THE NON-CORONARY PART OF THE VALVE. BY FURTHER INVESTIGATION, A NOT COMPLETELY UNFOLDED VALVE IN THE NON-CORONARY SIDE WAS DETECTED. THE VALVE WAS REMOVED AND IMPLANTED BACK AGAIN. IN THE SECOND ATTEMPT THE BALLOONING TOOK PLACE WITH THE PRESSURE OF 5ATM FOR 30 SECONDS. THE SAME UNFOLDING ISSUE IN THE SAME SPOT OCCURRED. AT THE END, THE DECISION OF REMOVING THE VALVE HAS BEEN MADE. THE DOCTOR ENLARGED THE AORTIC ROOT WITH THE DACRON-PATCH, RESIZED THE ANNULUS AND DECIDED TO IMPLANT THE MAGNA EASE AORTIC VALVE 21MM. ACCORDING TO THE INFORMATION RECEIVED THE PATIENT WAS STABLE DURING THE SURGERY, AND NO ADVERSE IMPACT ON THE PATIENT HAS BEEN REPORTED.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 13213246 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under P150011. One submission often covers many models, so check the product and lot details in each record.

• Z-0716-2017 · Oct 31, 2016 · Terminated
  Perceval Sutureless Aortic Heart Valve size S, Item # ICV1208, REF PVS21; Perceval Sutureless Aortic Heart Valve size M, Item # ICV1209, REF PVS23; Perceval Sutureless Aortic Heart