PERCEVAL PLUSRecalls & reported problems across all models

We found 4 models of PERCEVAL PLUS by Corcym Srl in the FDA's device registry (GUDID). Together they are named in 92 adverse event reports in the FDA's MAUDE database, received between Apr 5, 2022 and Sep 30, 2026 — classified as 2 deaths, 76 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Incomplete Coaptation” (18 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 PLUS problems

PERCEVAL PLUS models

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

• PERCEVAL PLUS PVF-M

  Heart-Valve, Non-Allograft Tissue
  31 reports
• PERCEVAL PLUS PVF-S

  Heart-Valve, Non-Allograft Tissue
  1 death25 reports
• PERCEVAL PLUS PVF-L

  Heart-Valve, Non-Allograft Tissue
  1 death20 reports
• PERCEVAL PLUS PVF-XL

  Heart-Valve, Non-Allograft Tissue
  16 reports

Recent PERCEVAL PLUS adverse event reports

The 15 most recent reports across all models, 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 27, 2026Leak/Splash

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909496 ↗
• InjurySep 27, 2026Leak/Splash

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50909495 ↗
• InjurySep 23, 2026Deformation Due to Compressive Stress

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 50868767 ↗
• 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 ↗
• InjurySep 11, 2026Degraded; Gradient Increase

  Patient problems: Aortic Valve Stenosis

  MAUDE report 50740616 ↗
• InjuryJun 20, 2026Migration

  THE MANUFACTURER WAS NOTIFIED OF AN EXPLANT INVOLVING A PERCEVAL PLUS VALVE. ON (B)(6) 2026, A PERCEVAL PLUS PVF-L VALVE WAS IMPLANTED IN A PATIENT. SHORTLY AFTER THE IMPLANTATION, THE PROSTHESIS BECAME LOOSENED AND MIGRATED FROM ITS INTENDED ANNULAR POSITION, RESULTING IN MALPOSITION WITHIN THE AORTA. THE PATIENT REQUIRED SECOND SURGERY SHORTLY AFTER THE FIRST SURGERY, AND THE VALVE WAS REPLACED WITH A TRADITIONAL SUTURE VALVE MAGNA EASE 23 MM. IT WAS INDICATED THAT THE ANNULUS WAS MEASURED THE THREE TIMES PRIOR CHOOSING LARGE (L) SIZE FOR THE PATIENT, THE PLACEMENT OF VALVE WAS VERIFIED AND ASSESSED USING TEE BEFORE THE WOUND WAS CLOSED. SURGICAL APPROACH WAS MICS, AND ISOLATED AVR WITH NO CONCOMITANT PROCEDURE. PATIENT¿S ANNULUS SIZED AS 26 X 21 MM, AREA OF 7.42 CM SQUARE. NO DEVICE MIS-SIZING WAS IDENTIFIED, NO ABNORMAL GEOMETRIES IN THE PATIENT¿S ANNULUS MENTIONED. NO POSITIONING DIFFICULTY NOTED AS THE IMPLANTATION OF THE VALVE WAS SUCCESSFUL IN THE FIRST TRY AFTER TRIPLE CHECKING THE SIZE WITH SIZER. REPORTEDLY, PATIENT WAS TAKEN INTO THE OR FOR THE SECOND TIME ON THE SAME DAY. NO DELAY IN THE FIRST SURGERY AND FOR THE SECOND SURGERY (REOPEN) THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25569071 ↗
• InjuryMay 28, 2026Incomplete Coaptation

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE. A PERCEVAL PLUS VALVE PVF-M WAS ATTEMPTED TO BE IMPLANTED IN A FEMALE PATIENT ON (B)(6) 2026. DURING THE PROCEDURE, A BALLOON DILATATION WAS PERFORMED AT 6 BARS BY ANOTHER MEMBER OF THE SURGICAL TEAM. THE PRIMARY SURGEON WAS NOT DIRECTLY INVOLVED IN THIS STEP DUE TO THE COMPLEXITY OF THE PROCEDURE BUT REPORTED THAT THE PERFUSIONIST CONFIRMED THE PRESSURE USED. SUBSEQUENTLY, THE VALVE DEMONSTRATED CENTRAL INSUFFICIENCY, WHICH LED TO THE DECISION TO EXPLANT THE DEVICE. THE PATIENT UNDERWENT SURGERY FOR COMBINED AORTIC VALVE DISEASE (AORTIC INSUFFICIENCY AND AORTIC STENOSIS) ALONG WITH CORONARY ARTERY DISEASE REQUIRING BYPASS SURGERY. AFTER IMPLANTATION OF THE PERCEVAL VALVE, THREE PHYSICIANS ASSESSED THE RESULTING VALVE PERFORMANCE. THERE WAS UNCERTAINTY AMONG THEM REGARDING THE SEVERITY OF THE CENTRAL INSUFFICIENCY. INTRAOPERATIVE ULTRASOUND SUGGESTED ONLY MILD INSUFFICIENCY; HOWEVER, DUE TO THE LACK OF CONSENSUS AND CONCERN OVER THE VALVE FUNCTION, THE DECISION WAS MADE TO PROCEED WITH EXPLANTATION. FOLLOWING EXPLANTATI

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 25314799 ↗
• InjuryMay 10, 2026Calcified

  THE MANUFACTURER WAS NOTIFIED THAT A PERCEVAL PLUS PVF-S VALVE WHICH WAS IMPLANTED IN PATIENT ON (B)(6) 2022, WAS EXPLANTED AFTER 4 YEARS, ON (B)(6) 2026 DUE TO ADVANCED DEGENERATION WITH SEVERE CALCIFICATION. REPORTEDLY, EDWARDS INSPIRIS 19MM WAS IMPLANTED INSTEAD. REPORTEDLY, PATIENT HAD TO COME BACK POST REOPERATION DUE TO SOME BLEEDING AND IS NOW RECOVERING. NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Insufficient Information

  MAUDE report 25133275 ↗
• InjuryApr 21, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED FROM THE MANTRA STUDY DATABASE OF THE EARLY EXPLANT OF A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER. A PERCEVAL PLUS PVF-S VALVE WAS SUCCESSFULLY IMPLANTED IN A FEMALE PATIENT ON (B)(6) 2022. AT THE 3-YEAR FOLLOW-UP VISIT, ECHOCARDIOGRAPHY REVEALED A MEAN AORTIC PRESSURE GRADIENT OF 68 MMHG, MODERATE CENTRAL REGURGITATION, AND A LEFT VENTRICULAR EJECTION FRACTION OF 50%. FUNCTIONALLY, THE PATIENT WAS CLASSIFIED AS NYHA CLASS III PRIOR TO THE INITIAL PERCEVAL VALVE IMPLANTATION, IMPROVED TO NYHA CLASS II FOLLOWING THE PROCEDURE, AND SUBSEQUENTLY DETERIORATED TO NYHA CLASS III AT THE 3-YEAR POSTOPERATIVE FOLLOW-UP. THE PATIENT PRESENTED AGAIN ON (B)(6) 2026 WITH SEVERE AORTIC STENOSIS. FOLLOWING DIAGNOSTIC EVALUATION AND HOSPITALIZATION, THE PROSTHETIC VALVE WAS EXPLANTED ON (B)(6) 2026 AND REPLACED VIA MEDIAN STERNOTOMY WITH A 19-MM BICARBON FITLINE VALVE (SN (B)(6)). THE PATIENT'S MEDICAL HISTORY INCLUDES SYSTEMIC HYPERTENSION, TYPE II NON-INSULIN-DEPENDENT DIABETES MELLITUS, DYSLIPIDEMIA, CURRENT TOBACCO USE, AND OBESITY.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24939216 ↗
• InjuryMar 25, 2026Deformation Due to Compressive Stress

  THE MANUFACTURER WAS NOTIFIED OF AN INTRAOPERATIVE EXPLANT INVOLVING A PERCEVAL PLUS VALVE. THE FOLLOWING PROVIDES A SUMMARY OF ALL INFORMATION CURRENTLY AVAILABLE TO THE MANUFACTURER FROM THE FACILITY. ON (B)(6) 2026, A PERCEVAL PLUS VALVE PVF-L WAS IMPLANTED AND THE AORTA WAS CLOSED. DUE TO ECHO RESULTS, THE AORTA WAS RE-OPENED AND IT WAS OBSERVED THAT THE PERCEVAL VALVE WAS NOT EXPANDED PROPERLY. CONSEQUENTLY, THE VALVE WAS EXPLANTED AND REPLACED WITH A MEDTRONIC HANCOCK II 25 MM VALVE. THE ORIGINAL VALVE WAS SUBSEQUENTLY DISPOSED OF BY THE SITE. NO ADDITIONAL DETAILS REGARDING THE EVENT, PATIENT OUTCOME, OR DIAGNOSTIC IMAGES DEMONSTRATING THE REPORTED INFOLDING ARE AVAILABLE AT THIS TIME.

  Patient problems: Aortic Valve Insufficiency/ Regurgitation

  MAUDE report 24687539 ↗
• InjuryMar 19, 2026Degraded

  THE MANUFACTURER WAS NOTIFIED OF A RE-INTERVENTION INVOLVING A PERCEVAL PLUS VALVE. BASED ON THE INFORMATION RECEIVED, ON (B)(6) 2021, A PERCEVAL PLUS VALVE, PVF-M, WAS IMPLANTED IN A PATIENT. AFTER ABOUT 5 YEARS, THE PATIENT WAS COMING IN FOR SURGERY ON (B)(6) 2026 TO HAVE THE PERCEVAL VALVE EXPLANTED DUE TO AORTIC STENOSIS. WHILE GAINING ACCESS TO THE HEART, THE SURGEON REPORTED VERY DIFFICULT ADHESIONS, AND HE COULD NOT ACCESS THE AORTA SAFELY. THEY HAD TO ABORT THE REDO AVR SURGICAL APPROACH AND PLANNED FOR A TAVI PROCEDURE. THIS PATIENT HAD A TAVI COMPLETED ON (B)(6) 2026 AND RECEIVED A SAPIEN 26MM TAVI VALVE.

  Patient problems: Aortic Valve Stenosis

  MAUDE report 24645853 ↗

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