PERCEVAL PLUS PVF-XL (UDI 08022057015396)Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 08022057015396), received between May 26, 2023 and Sep 30, 2026 — classified as 13 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (6 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Migration

  The manufacturer was notified of the explant of a Perceval Plus size XL valve. The following provides a summary of all information currently available to the manufacturer from the healthcare facility. On (b)(6)2026, an aortic valve replacement surgery was conducted using a Perceval Plus heart valve size XL. In the post-operative period, the patient developed hypotension and acidosis. During the echocardiogram (ECHO) evaluation performed after the procedure, it was observed that the valve had displaced from its original position causing a severe aortic regurgitation, and the non-coronary leaflet of the valve showed an anomalous behaviour. The patient was taken back to the operating room the same day for reoperation to explant the valve. During the intraoperative assessment, the Perceval valve was explanted and examined for potential reimplantation. The explanted valve was attempted to be collapsed and difficulties were encountered as they were not able to fit the valve properly into the Delivery System. As a result, the valve was successfully replaced with another new Perceval Plus size XL valve.

  Patient problems: Low Blood Pressure/ Hypotension; Respiratory Acidosis

  MAUDE report 50943607 ↗
• InjurySep 30, 2026Migration

  The manufacturer was notified of an explant involving a Perceval Plus heart valve. The following provides a summary of all information currently available to the manufacturer from the healthcare facility. On (b)(6) 2026, the patient underwent coronary artery bypass grafting (CABG) and aortic valve replacement (AVR) with a Perceval Plus size XL bioprosthesis. Subsequently, the patient was evaluated in the postoperative period due to the development of acute pulmonary edema. Echocardiographic examination revealed that the implanted Perceval Plus valve had become displaced from its original position. Consequently, the patient underwent re-operation on (b)(6) 2026. During the intraoperative assessment, the Perceval valve was explanted and examined for potential reimplantation. The explanted valve was attempted to be collapsed and difficulties were encountered as they were not able to fit the valve properly into the Delivery System. Subsequent inspection revealed a deformation in the inflow section of the valve. As a result, the valve was replaced with another new Perceval Plus size XL valve.

  Patient problems: Pulmonary Edema

  MAUDE report 50943492 ↗
• InjurySep 30, 2026Patient-Device Incompatibility

  The manufacturer was notified of a pacemaker implant involving a Perceval Plus heart valve through Mantra study. Based on the information available, on (b)(6) 2026, a Perceval Plus heart valve size XL was implanted in a patient. On (b)(6)2026 , the patient experienced complete atrioventricular block. As such, a decision was made on (b)(6) 2026 to implant a permanent pacemaker. This procedure was done on (b)(6) 2026. The outcome has been reported as Recovered/Resolved W. Sequelae. The patient's clinical history included: Coronary artery disease; Diabetes Mellitus: Type II, Non-insulin dependent; Dyslipidemia; Systemic Hypertension; Tobacco history: Previous; Other disease: iron-deficiency anemia, chronic pancreatitis, moderate pericardial effusion; and NYHA Class II.

  Patient problems: Heart Block

  MAUDE report 50941880 ↗
• InjurySep 20, 2026Incomplete Coaptation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50834815 ↗
• InjurySep 20, 2026Incomplete Coaptation

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50834814 ↗
• MalfunctionFeb 11, 2026Leak/Splash

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS PROSTHESIS. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. DURING AN ISOLATED AORTIC VALVE REPLACEMENT (AVR) SURGERY PERFORMED ON (B)(6) 2026 THROUGH RIGHT ANTERIOR THORACOTOMY, A PERCEVAL PLUS VALVE PVF-XL WAS IMPLANTED BASED ON THE ANNULUS SIZING RESULTS, IN A PATIENT WITH A BICUSPID TYPE 1 STENOTIC NATIVE VALVE. NO DIFFICULTIES WERE EXPERIENCED DURING THE COLLAPSING OR RELEASING OF THE VALVE AND THE IMPLANTATION WAS SUCCESSFUL ON THE FIRST ATTEMPT. HOWEVER, IMMEDIATELY AFTER IMPLANTATION, INTRAOPERATIVE ECHOCARDIOGRAPHIC EVALUATION REVEALED A SIGNIFICANT LEAK, BOTH PARAVALVULAR AND CENTRAL. BASED ON THE MEDICAL JUDGMENT RECEIVED, EVEN IF CALCIFICATIONS WERE PRESENT AT THE ANNULUS, THEY DID NOT INTERFERE WITH THE EXPANSION OF THE STENT. THE AORTA WAS PROMPTLY RE-OPENED FOR FURTHER INSPECTION. UPON DIRECT VISUAL ASSESSMENT BY THE SURGICAL TEAM, THE LEAK WAS DETERMINED TO BE CAUSED BY A DEFECT IN THE VALVE ITSELF, AND THE DEVICE WAS IMMEDIATELY EXPLANTED. SUBSEQUENTLY, THE VALVE WAS REPLACED WITH A CONVENTIONAL BIOPROSTHETIC VALVE FROM ANOTHER MANUFACTU

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24311850 ↗
• InjuryNov 14, 2025Migration; Migration

  THE MANUFACTURER WAS INFORMED OF A DISPLACEMENT OF A PERCEVAL PLUS PVF-XL SUTURELESS AORTIC PROSTHESIS OCCURRED IN THE IMMEDIATE POST-OPERATIVE PERIOD, LEADING TO AN EMERGENCY REOPERATION APPROXIMATELY TWO HOURS AFTER THE SURGERY. AS REPORTED, THE VALVE HAD BEEN IMPLANTED VIA FULL STERNOTOMY FOR AN ELECTIVE SURGERY ON (B)(6) 2025 AND SUPRACORONARY REPLACEMENT OF THE ASCENDING AORTA WITH A STRAIGHT DACRON GRAFT HAD BEEN PERFORMED AS CONCOMITANT PROCEDURE. ACCORDING TO THE DATA RECEIVED, THE PATIENT¿S NATIVE VALVE WAS BICUSPID TYPE I AND PRESENTING DOUBLE LESION (MODERATE CALCIFIED STENOSIS AND MILD REGURGITATION). NO DIFFICULTIES WERE NOTED BOTH IN COLLAPSING AND POSITIONING THE PROSTHESIS. IT IS NOT KNOWN TO THE MANUFACTURER IF BALLOONING OF THE PERCEVAL PROSTHESIS WAS PERFORMED AS PER IFUS. REPORTEDLY, AFTER THE SURGERY THE PATIENT EXPERIENCED A DISPLACEMENT OF THE PERCEVAL VALVE TOWARD THE ASCENDING AORTA, LEADING TO A SEVERE PARAVALVULAR LEAK OCCUPYING MORE THAN 50% OF THE ANNULUS CIRCUMFERENCE WHICH CAUSED SEVERE AORTIC REGURGITATION (OCCUPYING 100% OF THE LVOT, MEAN GRADIENT 6 MMHG, PHT 101 MS, LVEF 50%). DURING THE IMMEDIATE POSTOPERATIVE COURSE, THE PATIENT PRESENTED CARDIOR

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 23553812 ↗
• InjurySep 4, 2025Perivalvular Leak; Perivalvular Leak

  ON (B)(6) 2025, A PERCEVAL VALVE PVF-XL WAS IMPLANTED IN A PATIENT. AS REPORTED, THIS WAS TO REPLACE THE PREVIOUSLY IMPLANTED SIMILAR DEVICE PVF-XL DUE TO ENDOCARDITIS AFTER MORE THAN A YEAR. THIS SECOND PVF-XL WAS ALSO EVENTUALLY EXPLANTED AT AN UNKNOWN DATE DUE TO SEVERE PVL AND REPLACED WITH A 29 MM EDWARDS INSPIRIS VALVE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22968139 ↗
• InjuryAug 15, 2025Difficult or Delayed Separation; Difficult or Delayed Separation

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS HEART VALVE, PVF-XL THAT OCCURRED ON (B)(6) 2025. AS REPORTED, THE SIZING WAS PERFORMED WITHOUT DIFFICULTIES AND WAS CORRESPONDING TO ECHO MEASUREMENTS. HOWEVER, DURING THE RELEASE PHASE THE PROSTHESIS OPENED ASYMMETRICALLY, WITH ONE THIRD OF THE VALVE OPENING PREMATURELY AND PUSHING THE PROSTHESIS BACK OUT OF ONE SINUS. REPORTEDLY, THREE ATTEMPTS WERE MADE BUT THE SAME BEHAVIOR WAS EXPERIENCED. ACCORDING TO THE INFORMATION PROVIDED, THE PATIENT¿S ANATOMICAL CONFIGURATION INCLUDED AN AORTIC ROOT WITH A NON-CORONARY SINUS THAT WAS SOMEWHAT ENLARGED RELATIVE TO THE RIGHT AND LEFT CORONARY SINUSES. ULTIMATELY, THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY IMPLANTING A SUTURED BIOPROSTHESIS FROM A DIFFERENT MANUFACTURER (EDWARDS LIFESCIENCES MAGNA EASE, SIZE 25), WITH NO REPORTED ADVERSE EVENTS OR COMPLICATIONS FOR THE PATIENT. REPORTEDLY, THE COMMISSURES WERE FUSED BUT THERE WAS A PERFECT SYMMETRY REMAINING OF THE CUSPS. BASED ON THE FURTHER INFORMATION RECEIVED, THE PROCEDURE WAS AN ISOLATED MICS SURGERY AND PATIENT REMAINED STABLE THROUGH THE SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22820483 ↗
• InjuryAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORM INDICATED THAT A PERCEVAL PLUS HEART VALVE, PVF-XL WAS "EXPLANTED/INACTIVE" DURING THE PROCEDURE PERFORMED ON (B)(6) 2025. NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT ANY DEVICE DYSFUNCTION, DELAY IN THE PROCEDURE OR PATIENT OUTCOME AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22798361 ↗
• InjuryAug 13, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  MANUFACTURER BECAME AWARE OF THE FOLLOWING EVENT THROUGH DEVICE TRACKING DEPARTMENT. BASED ON THE INFORMATION ON THE PATIENT REGISTRATION FORM INDICATED THAT A PERCEVAL PLUS HEART VALVE, PVF-XL WAS "EXPLANTED/INACTIVE" DURING THE PROCEDURE PERFORMED ON (B)(6) 2025 . NO FURTHER INFORMATION HAS BEEN RECEIVED ABOUT ANY DEVICE DYSFUNCTION, DELAY IN THE PROCEDURE OR PATIENT OUTCOME AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 22798341 ↗
• InjuryMay 29, 2025Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SIZE XL THAT OCCURRED ON (B)(6) 2025. REPORTEDLY, A CT SCAN WAS INITIALLY USED TO ASSESS THE ANATOMY AND GUIDE VALVE SIZING, WHICH WAS FOLLOWED BY TACTILE SIZING. BASED ON THESE EVALUATIONS, AN XL PERCEVAL PLUS VALVE WAS SELECTED TO BE IMPLANTED. HOWEVER, AFTER CLOSURE OF THE AORTOTOMY AND UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), A SIGNIFICANT CENTRAL LEAK WAS OBSERVED. AS A RESULT, THE PERCEVAL PLUS VALVE WAS EXPLANTED, AND A SUTURED INSPIRIS VALVE SIZE 25 WAS IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22111079 ↗
• InjuryMay 29, 2025Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF AN INTRA-OPERATIVE EXPLANT OF A PERCEVAL PLUS SIZE XL THAT OCCURRED ON (B)(6) 2025. REPORTEDLY, A CT SCAN WAS INITIALLY USED TO ASSESS THE ANATOMY AND GUIDE VALVE SIZING, WHICH WAS FOLLOWED BY TACTILE SIZING. BASED ON THESE EVALUATIONS, AN XL PERCEVAL PLUS VALVE WAS SELECTED TO BE IMPLANTED. HOWEVER, AFTER CLOSURE OF THE AORTOTOMY AND UNDER TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE), A SIGNIFICANT CENTRAL LEAK WAS OBSERVED. AS A RESULT, THE PERCEVAL PLUS VALVE WAS EXPLANTED, AND A SUTURED INSPIRIS VALVE SIZE 25 WAS IMPLANTED IN THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 22110970 ↗
• MalfunctionSep 19, 2024Incomplete Coaptation; Incomplete Coaptation

  THE MANUFACTURER WAS INFORMED OF AN ATTEMPT TO IMPLANT A PERCEVAL PLUS PROSTHESIS SIZE XL DURING A SURGERY PERFORMED THROUGH MICS APPROACH. BASED ON THE INFORMATION RECEIVED, CABG WAS PERFORMED PRIOR TO PERCEVAL IMPLANT. NO DIFFICULTIES WERE ENCOUNTERED DURING THE VALVE COLLAPSING AND POSITIONING, NOR DURING THE SIZING PROCEDURE. NO ABNORMAL GEOMETRIES OR ANATOMICAL FEATURES WERE NOTED ON THE PATIENT¿S NATIVE AORTIC ANULUS AND VALVE. REPORTEDLY, AFTER IMPLANT A MASSIVE CENTRAL LEAK OCCURRED WHICH LED TO THE DECISION TO EXPLANT THE PROSTHESIS. NO INFORMATION IS AVAILABLE TO THE MANUFACTURER REGARDING THE REPLACEMENT DEVICE. AS PER INFORMATION RECEIVED, THE PATIENT WAS NOT AFFECTED IN CONSEQUENCE OF THE EVENT, WHICH CAUSED A DELAY IN SURGICAL TIME OF APPROXIMATELY 40 MINUTES. NO DIAGNOSTIC IMAGES, BOTH PRE-OPERATIVE AND INTRA-OPERATIVE, ARE AVAILABLE TO THE MANUFACTURER FOR ANALYSIS AT THIS STAGE.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 20254281 ↗
• InjuryJan 3, 2024Leak/Splash; Leak/Splash

  THE MANUFACTURER WAS INFORMED OF THE FOLLOWING EVENT THROUGH MANTRA STUDY DATABASE. REPORTEDLY, A PERCEVAL PLUS VALVE SIZE XL WAS IMPLANTED IN THE PATIENT ON (B)(6)2022. BASED ON THE INFORMATION RECEIVED, PATIENT HAD PARAVALVULAR REGURGITATION THAT STARTED ON (B)(6) 2023. THE PATIENT WAS HOSPITALIZED FOR EVALUATION OF PVL IDENTIFIED IN TTE CONDUCTED ON (B)(6) 2023, AND DISCHARGED AFTER EXAMINATION. THE EVENT SEVERITY WAS CONSIDERED MILD, AND NO ACTION HAS YET BEEN TAKEN. AS REPORTED, PATIENT'S CLINICAL HISTORY INCLUDED ANGINA; SYSTEMIC HYPERTENSION; DYSLIPIDEMIA; OBESITY; TYMPANITES (50 YEARS AGO); AND PATIENT WAS NYHA CLASS III.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 18439954 ↗
• MalfunctionMay 26, 2023Incomplete Coaptation; Intravalvular regurgitation; Incomplete Coaptation; Intravalvular regurgitation

  ON (B)(6) 2022, AFTER IMPLANTING PERCEVAL PLUS VALVE PVF-XL THROUGH FULL STERNOTOMY, CENTRAL LEAK WAS DETECTED IN THE ECHO IMAGING, AND IT WAS DISCOVERED THAT THE LEAFLETS WERE NOT COAPTATING. CONSEQUENTLY, IT WAS DECIDED TO EXPLANT AND RE-IMPLANT THE VALVE. HOWEVER, DESPITE REPEATING THE PROCEDURE, CENTRAL LEAK IN ECHO IMAGING PERSISTED, LEADING TO REMOVAL OF THE VALVE. ULTIMATELY, EDWARDS INSPIRIS RESILIA VALVE 25 MM WAS UTILIZED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. REPORTEDLY, UPON EXAMINING THE EXPLANTED PVF VALVE, IT WAS DISCOVERED THAT ONE OF THE LEAFLETS WAS SHORTER THAN THE OTHERS. BASED ON THE FURTHER INFORMATION RECEIVED, NO PVF VALVE MALFUNCTION OR MIS-SIZING WERE IDENTIFIED PRIOR TO THE EVENT. THE PROCEDURE WAS A COMBINED CORONARY ARTERY BYPASS GRAFTING AND AORTIC VALVE REPLACEMENT (CABG-AVR), AND THE PATIENT GEOMETRIES WERE NOT CONSIDERED ABNORMAL. THE PROCEDURE WAS DELAYED BY ONE HOUR, BUT PATIENT REMAINED IN STABLE CONDITION THROUGHOUT THE PROCEDURE. THERE WAS NO ADDITIONAL DEBRIDEMENT OR ANNULAR RESTRUCTURING PERFORMED PRIOR TO THE SECOND VALVE IMPLANT. BASED ON THE FURTHER INFORMATION RECEIVED, CABG PROCEDURE WAS PERFORMED PRIOR TO T

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 17011100 ↗

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