PERCEVAL PVS21 (UDI 08022057014696)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08022057014696), received between Dec 31, 2021 and Feb 25, 2026 — classified as 1 death, 3 injuries.

The most frequently reported specific device problem is “Degraded” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 25, 2026Calcified

  THE MANUFACTURER WAS NOTIFIED OF A RE-DO SURGERY INVOLVING A PERCEVAL S SUTURELESS AORTIC HEART VALVE, SIZE S. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM THE FACILITY. ON (B)(6) 2021, A PERCEVAL VALVE PVS21 WAS SUCCESSFULLY IMPLANTED. THE PROSTHESIS WAS EXPLANTED ON (B)(6) 2026 DUE TO STRUCTURAL VALVE DETERIORATION. IT WAS REPORTED AS A CALCIFIED VALVE WITH ONE LEAFLET FROZEN. THE SURGEON REMOVED THE PERCEVAL PROSTHESIS BY CUTTING IT AND IMPLANTED A CARBOMEDICS TOP HAT MECHANICAL VALVE SIZE 21 AS A REPLACEMENT. THE PATIENT IS CURRENTLY RECOVERING.

  Patient problems: Calcium Deposits/Calcification

  MAUDE report 24440573 ↗
• DeathNov 8, 2024Degraded; Adverse Event Without Identified Device or Use Problem; Degraded; Adverse Event Without Identified Device or Use Problem

  THE MANUFACTURER WAS INFORMED OF A PATIENT¿S DEATH OCCURRED ON(B)(6) 2024, FOLLOWING REDO SURGERY TO REPLACE A PERCEVAL PVS21 SUTURELESS AORTIC BIOPROSTHESIS DUE TO ENDOCARDITIS. REPORTEDLY, THE PATIENT DIDN¿T HAVE A PREVIOUS HISTORY OF ENDOCARDITIS. THE PERCEVAL VALVE HAD BEEN IMPLANTED VIA MEDIAN STERNOTOMY ON (B)(6) 2024, FOR DEGENERATIVE AORTIC STENOSIS. ACCORDING TO THE OPERATIONAL REPORT RECEIVED, A CONCOMITANT SINGLE VESSEL CABG (LIMA TO LAD) WAS PERFORMED WITHOUT INTRAOPERATIVE COMPLICATIONS. TOTAL CPB TIME WAS 90 MINUTES, AND TOTAL AORTIC CLAMP TIME WAS 62 MINUTES. THE PATIENT WAS STABLE AND EXTUBATED ON THE SECOND DAY POST-SURGERY. ON (B)(6) 2024, A CHEST X-RAY SHOWED A WHITE-OUT OF THE LEFT HEMITHORAX DESPITE THE PATIENT¿S STABLE CONDITION. A BRONCHOSCOPY REVEALED NO MUCOUS PLUG, AND A LEFT PLEURAL DRAIN WAS INSERTED, DRAINING A SIGNIFICANT AMOUNT OF HEMORRHAGIC EFFUSION SUGGESTIVE OF INFECTION. ANTIBIOTIC TREATMENT WAS ESCALATED, THE CHEST X-RAY IMPROVED, AND THE PATIENT WAS DISCHARGED HOME. THE PATIENT EXPERIENCED A RECURRENCE OF LEFT PLEURAL EFFUSION AND UNDERWENT ANOTHER BRONCHOSCOPY AND THORACOSCOPIC PLEURAL TOILET ON JUNE 20, 2024. THE PLEURAL FLUID LATER APPEARED

  Patient problems: Endocarditis

  MAUDE report 20639897 ↗
• InjuryDec 31, 2021Degraded; Degraded

  ON (B)(6) 2016, A PERCIVAL VALVE PVS21 WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR LEFT CARDIAC DECOMPENSATION WITH DISCOVERY OF DEGENERATION OF THE PERCIVAL BIOPROSTHESIS. ON (B)(6) 2021, THE CARDIAC ULTRASOUND SHOWED DEGENERATION OF THE PERCEVAL VALVE. A TAVI WAS SCHEDULED ON (B)(6) 2021 TO TREAT THE PATIENT. BASED ON ADDITIONAL INFORMATION RECEIVED, THE PREOPERATIVE ECHO (PERFORMED IN (B)(6) 2016) SHOWED PRESENCE OF CALCIFICATIONS IN THE NATIVE AORTIC VALVE (MEAN GRADIENT = 80MHG). THE POSTOPERATIVE ULTRASOUND SHOWED PRESERVED LVEF, MODERATE LV HYPERTROPHY (DETECTED ALSO PRE-OPERATIVELY) AND A MEAN TRANSAORTIC GRADIENT OF 17MMHG. THE ECHO PERFORMED ON (B)(6) 2021 BEFORE THE REOPERATION CONFIRMED THE DEGENERATION OF THE PERCEVAL VALVE PROSTHESIS RESULTING IN AORTIC STENOSIS (MEAN GRADIENT 69MMHG) AND MODERATE TO MEDIUM REGURGITATION.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation; Aortic Valve Stenosis; Heart Failure/Congestive Heart Failure

  MAUDE report 13125063 ↗
• InjuryDec 31, 2021Degraded; Degraded

  ON (B)(6) 2016, A PERCEVAL VALVE PVS21 WAS IMPLANTED. ON (B)(6) 2021, THE PATIENT WAS HOSPITALIZED FOR LEFT CARDIAC DECOMPENSATION WITH DISCOVERY OF DEGENERATION OF THE PERCEVAL BIOPROSTHESIS. ON (B)(6) 2021, THE CARDIAC ULTRASOUND SHOWED DEGENERATION OF THE PERCEVAL VALVE. A TAVI WAS SCHEDULED ON (B)(6) 2021 TO TREAT THE PATIENT.

  Patient problems: Heart Failure/Congestive Heart Failure

  MAUDE report 13125048 ↗

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